OPHTHALMIC CURETTE-VARIOUS
FDA 510(k) clearance K841007 · decided 1984-05-09
Clearance details
- K-number
- K841007
- Device name
- OPHTHALMIC CURETTE-VARIOUS
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-09
- Decision date
- 1984-05-09
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- HNZ
- 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 |
|---|---|---|
| LOOK CAPSULE POLISHERS/SCRAPERS (K870437) | Look, Inc. | 1987-02-20 |
Recalls involving this device
No recalls on record reference this clearance.