OMS/GONVERS RETINAL PERFORATOR
FDA 510(k) clearance K844448 · decided 1985-08-21
Clearance details
- K-number
- K844448
- Device name
- OMS/GONVERS RETINAL PERFORATOR
- Applicant
- Optical Micro Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-16
- Decision date
- 1985-08-21
- Days to decision
- 278 days
- Clearance type
- Traditional
- Product code
- HNM
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Danvers, MA, 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 |
|---|---|---|
| NEEDLEHOLDER, MICROVASULAR 5 1/2 (K780154) | Edward Weck, Inc. | 1978-03-17 |
Recalls involving this device
No recalls on record reference this clearance.