HYPAFIX DRESSING RETENTION SHEET
FDA 510(k) clearance K894254 · decided 1989-08-31
Clearance details
- K-number
- K894254
- Device name
- HYPAFIX DRESSING RETENTION SHEET
- Applicant
- Smith & Nephew United, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-20
- Decision date
- 1989-08-31
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- NAD
- Device class
- 1
- Regulation number
- 878.4020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (K102403) | Sam Medical Products | 2011-03-03 |
| APLION TOPICAL CARE SYSTEM (K091133) | Aplion Medical,Llc | 2009-05-20 |
| ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (K072560) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| CENTURION SORBAVIEW OTC (K080524) | Tri-State Hospital Supply Corp. | 2008-04-23 |
| DERMASTREAM (K060046) | Enzysurge , Ltd. | 2006-02-27 |
| OXYBAND WOUND DRESSING (K043063) | Oxyband Technologies, Inc. | 2005-03-24 |
| WET CHAMBER (K020781) | Kinetic Concepts, Inc. | 2002-05-06 |
| KERLIX MD ANTIMICROBIAL GAUZE DRESSING (K990530) | The Kendall Company, L.P. | 2000-01-31 |
| WOUND DRESSING/ABD PAD, MODEL #10810 (K990861) | Hospital Specialty Co. | 1999-04-12 |
| OTOSILK OTOLOGICAL GRAFT DRESSING (K964534) | Boston Medical Products, Inc. | 1997-04-09 |
| DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL (K960815) | Dumex Medical Surgical Products, Ltd. | 1996-04-29 |
| ALLDRESS MULTI LAYERED WOUND DRESSING (K955863) | Molnlycke/Scott Health Care | 1996-03-13 |
Recalls involving this device
No recalls on record reference this clearance.