The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Eff-effner Bulbs.
| Device ID | K844773 |
| 510k Number | K844773 |
| Device Name: | EFF-EFFNER BULBS |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| 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 | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-01-08 |