Panels › Ophthalmic › Product code HLR · Class 1
Keratoscope, Battery-Powered
Regulation 886.1350
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HLR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cutler Medical Instruments | 1 | 0 |
| Gamut Ent. | 1 | 0 |
| Jedmed Instrument Co. | 1 | 0 |
| Medical Equipment Designs, Inc. | 1 | 0 |
| The Sanborn Co. | 1 | 0 |
| Surgidev Corp. | 1 | 0 |
| Technitex, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 1990 | K901553 | SURG-K SURGICAL KERATOMETER The Sanborn Co. | HLR |
| Aug 4, 1988 | K882902 | QRK 100, QUALITATIVE RING KERATOSCOPE Technitex, Inc. | HLR |
| Jul 13, 1988 | K882618 | JEDMED/POLACK KERATOSCOPE HS/SL Gamut Ent. | HLR |
| Dec 29, 1986 | K864639 | REUSABLE SURGICAL KERATOSCOPE Jedmed Instrument Co. | HLR |
| Dec 27, 1985 | K854054 | PLACIDO DISC Cutler Medical Instruments | HLR |
| Jan 26, 1983 | K830008 | KARICKHOFF KERATOSCOPE Surgidev Corp. | HLR |
| May 24, 1982 | K821080 | HAND KERATOSCOPE Medical Equipment Designs, Inc. | HLR |
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