RAND NASAL PACKING
FDA 510(k) clearance K963856 · decided 1996-10-18
Clearance details
- K-number
- K963856
- Device name
- RAND NASAL PACKING
- Applicant
- Rand Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-25
- Decision date
- 1996-10-18
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- EMX
- Device class
- 1
- Regulation number
- 874.4100
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326) | Hemostasis, LLC | 2022-11-14 |
| NASALCEASE (K041446) | Les Laboratorires Brothier, S.A. | 2004-07-01 |
| RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108) | Bhk Holding | 2000-05-23 |
| HYLASINE (K993362) | Biomatrix, Inc. | 2000-03-13 |
| HYDROFERA BACTERISTATIC NASAL DRESSING (K983276) | Hydrofera, LLC | 1999-09-14 |
| MEROGEL NASAL DRESSING AND SINUS STENT (K982731) | Xomed, Inc. | 1999-02-02 |
| ENTAXIS NASAL PACKING (K984069) | Les Laboratorires Brothier, S.A. | 1999-01-25 |
| NOSEBLEED NOSECLIP (K981966) | Michael M. Knott, M.D. | 1998-08-14 |
| DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656) | Specialty Surgical Products, Inc. | 1997-11-18 |
| ULTRACELL PACKING WITH SLEEVE (K973085) | Ultracell Medical Technologies, Inc. | 1997-11-18 |
| VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922) | Interview Medical Technology Corp. | 1997-10-08 |
| RHINOCELL NASAL PACKINGS (K972459) | Boston Medical Products, Inc. | 1997-08-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S027) | Rand Scientific Corp. | 1994-01-26 |
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S026) | Rand Scientific Corp. | 1993-05-27 |
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S025) | Rand Scientific Corp. | 1993-02-09 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S024) | Rand Scientific Corp. | 1993-02-05 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S023) | Rand Scientific Corp. | 1992-09-30 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S022) | Rand Scientific Corp. | 1992-09-01 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S021) | Rand Scientific Corp. | 1992-06-26 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S020) | Rand Scientific Corp. | 1992-04-14 |