LOOK CAPSULE POLISHERS/SCRAPERS
FDA 510(k) clearance K870437 · decided 1987-02-20
Clearance details
- K-number
- K870437
- Device name
- LOOK CAPSULE POLISHERS/SCRAPERS
- Applicant
- Look, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-03
- Decision date
- 1987-02-20
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- HNZ
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Look
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPHTHALMIC CURETTE-VARIOUS (K841007) | Premier Dental Products Co. | 1984-05-09 |
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 |