The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Binocular Loupe.
| Device ID | K830878 |
| 510k Number | K830878 |
| Device Name: | BINOCULAR LOUPE |
| Classification | Loupe, Binocular, Low Power |
| Applicant | ALMORE INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HJH |
| CFR Regulation Number | 886.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-18 |
| Decision Date | 1983-04-06 |