The following data is part of a premarket notification filed by Farah Ltd. with the FDA for Marne M.t.p.j. Orthopedic Implant.
Device ID | K781380 |
510k Number | K781380 |
Device Name: | MARNE M.T.P.J. ORTHOPEDIC IMPLANT |
Classification | Prosthesis, Finger, Constrained, Polymer |
Applicant | FARAH LTD. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | KYJ |
CFR Regulation Number | 888.3230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-11 |
Decision Date | 1979-02-21 |