The following data is part of a premarket notification filed by Protek, Inc. with the FDA for M.w.p. Wrist Prosthesis.
Device ID | K872502 |
510k Number | K872502 |
Device Name: | M.W.P. WRIST PROSTHESIS |
Classification | Prosthesis, Wrist, Semi-constrained |
Applicant | PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
Contact | Kenneth Epling |
Correspondent | Kenneth Epling PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
Product Code | KWM |
CFR Regulation Number | 888.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-24 |
Decision Date | 1987-07-23 |