THE NAUTILUS
FDA 510(k) clearance K961124 · decided 1996-04-19
Clearance details
- K-number
- K961124
- Device name
- THE NAUTILUS
- Applicant
- Rand Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-21
- Decision date
- 1996-04-19
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FZE
- Device class
- 2
- Regulation number
- 878.3680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |