The following data is part of a premarket notification filed by Effner, Inc. with the FDA for Effner Arthroperiscope/arthroscope W/remov. Optics.
Device ID | K900680 |
510k Number | K900680 |
Device Name: | EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS |
Classification | Arthroscope |
Applicant | EFFNER, INC. POST OFFICE BOX 191 Port Washington, NY 11050 |
Contact | Emmanuel Anapliotis |
Correspondent | Emmanuel Anapliotis EFFNER, INC. POST OFFICE BOX 191 Port Washington, NY 11050 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-12 |
Decision Date | 1990-03-29 |