HJH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Loupe, Binocular, Low Power
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5120
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MALIS SURGICAL LOUPES (K874845) | Valley Forge Scientific Corp. | 1987-12-23 |
| EXETER OPERATING LOUPE (K863983) | Exeter Instruments, Inc. | 1986-11-10 |
| BINOCULAR LOUPE (K830878) | Almore Intl., Inc. | 1983-04-06 |
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