NEEDLEHOLDER, MICROVASULAR 5 1/2
FDA 510(k) clearance K780154 · decided 1978-03-17
Clearance details
- K-number
- K780154
- Device name
- NEEDLEHOLDER, MICROVASULAR 5 1/2
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-30
- Decision date
- 1978-03-17
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- HNM
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| OMS/GONVERS RETINAL PERFORATOR (K844448) | Optical Micro Systems, Inc. | 1985-08-21 |
Recalls involving this device
No recalls on record reference this clearance.