The following data is part of a premarket notification filed by Seiler Instrument & Mfg. Co., Inc. with the FDA for Low-power Binocular Loupe.
| Device ID | K875124 |
| 510k Number | K875124 |
| Device Name: | LOW-POWER BINOCULAR LOUPE |
| Classification | Spectacle, Operating (loupe), Ophthalmic |
| Applicant | SEILER INSTRUMENT & MFG. CO., INC. 170 E. KIRKHAM St. Louis, MO 63119 |
| Contact | Pearl Reilly |
| Correspondent | Pearl Reilly SEILER INSTRUMENT & MFG. CO., INC. 170 E. KIRKHAM St. Louis, MO 63119 |
| Product Code | HOH |
| CFR Regulation Number | 886.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-02-19 |