LOOK VISCODISSECTOR
FDA 510(k) clearance K913530 · decided 1991-10-21
Clearance details
- K-number
- K913530
- Device name
- LOOK VISCODISSECTOR
- Applicant
- Look, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-08
- Decision date
- 1991-10-21
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Ada, OK, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S004) | Look, Inc. | 1990-09-12 |
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S002) | Look, Inc. | 1986-06-09 |
| POLYVIOLENE SUTURE (N80950/S003) | Look, Inc. | 1986-06-09 |
| POLYVIOLENE SUTURE (N80950/S002) | Look, Inc. | 1986-02-28 |
| POLYVIOLENE SUTURE (N80950/S001) | Look, Inc. | 1985-03-22 |
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S001) | Look, Inc. | 1985-03-22 |