ASCENSION SILLICONE MCP


Device Classification Name

prosthesis, finger, constrained, polymer

510(k) Number K022892
Device Name ASCENSION SILLICONE MCP
Original Applicant
ASCENSION ORTHOPEDICS, INC.
8200 cameron rd., suite c-140
austin, 
TX 
78754 -3832

Original Contact robert m wolfarth
Regulation Number 888.3230
Classification Product Code
KYJ  
Date Received 08/30/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No