The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Effner-eye Cautery With Battery Handle.
| Device ID | K844775 |
| 510k Number | K844775 |
| Device Name: | EFFNER-EYE CAUTERY WITH BATTERY HANDLE |
| Classification | Unit, Cautery, Thermal, Ac-powered |
| Applicant | MECRON MEDICAL PRODUCTS, INC. 938 PORT WASHINGTON BLVD. P.O. BOX 1139 Port Washington, NY 11050 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MECRON MEDICAL PRODUCTS, INC. 938 PORT WASHINGTON BLVD. P.O. BOX 1139 Port Washington, NY 11050 |
| Product Code | HQO |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-08-12 |