The following data is part of a premarket notification filed by American V. Mueller with the FDA for Anis Irrigating Spatula.
| Device ID | K810937 |
| 510k Number | K810937 |
| Device Name: | ANIS IRRIGATING SPATULA |
| Classification | Spatula, Ophthalmic |
| Applicant | AMERICAN V. MUELLER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HND |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-07 |
| Decision Date | 1981-05-15 |