M.W.P. WRIST PROSTHESIS

Prosthesis, Wrist, Semi-constrained

PROTEK, INC.

The following data is part of a premarket notification filed by Protek, Inc. with the FDA for M.w.p. Wrist Prosthesis.

Pre-market Notification Details

Device IDK872502
510k NumberK872502
Device Name:M.W.P. WRIST PROSTHESIS
ClassificationProsthesis, Wrist, Semi-constrained
Applicant PROTEK, INC. 5780 WEST 71ST ST. Indianapolis,  IN  46278
ContactKenneth Epling
CorrespondentKenneth Epling
PROTEK, INC. 5780 WEST 71ST ST. Indianapolis,  IN  46278
Product CodeKWM  
CFR Regulation Number888.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-24
Decision Date1987-07-23

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