SURG-K SURGICAL KERATOMETER
FDA 510(k) clearance K901553 · decided 1990-07-20
Clearance details
- K-number
- K901553
- Device name
- SURG-K SURGICAL KERATOMETER
- Applicant
- The Sanborn Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-03
- Decision date
- 1990-07-20
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- HLR
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Clara, CA, 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 |
|---|---|---|
| QRK 100, QUALITATIVE RING KERATOSCOPE (K882902) | Technitex, Inc. | 1988-08-04 |
| JEDMED/POLACK KERATOSCOPE HS/SL (K882618) | Gamut Ent. | 1988-07-13 |
| 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.