JEDMED/POLACK KERATOSCOPE HS/SL
FDA 510(k) clearance K882618 · decided 1988-07-13
Clearance details
- K-number
- K882618
- Device name
- JEDMED/POLACK KERATOSCOPE HS/SL
- Applicant
- Gamut Ent.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-24
- Decision date
- 1988-07-13
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- HLR
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Snellville, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gamut Ent.
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 |
|---|---|---|
| SURG-K SURGICAL KERATOMETER (K901553) | The Sanborn Co. | 1990-07-20 |
| QRK 100, QUALITATIVE RING KERATOSCOPE (K882902) | Technitex, Inc. | 1988-08-04 |
| REUSABLE SURGICAL KERATOSCOPE (K864639) | Jedmed Instrument Co. | 1986-12-29 |
| PLACIDO DISC (K854054) | Cutler Medical Instruments | 1985-12-27 |
| KARICKHOFF KERATOSCOPE (K830008) | Surgidev Corp. | 1983-01-26 |
| HAND KERATOSCOPE (K821080) | Medical Equipment Designs, Inc. | 1982-05-24 |
Recalls involving this device
No recalls on record reference this clearance.