The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Effner Fiber Optic Cables For Cold Light Transmiss.
Device ID | K844774 |
510k Number | K844774 |
Device Name: | EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS |
Classification | Light Source, Photographic, Fiberoptic |
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 | FCR |
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 | 1985-04-22 |