FDA 510(k) Application Details - K973385

Device Classification Name	Prosthesis, Tendon, Passive   More FDA Info for this Device
510(K) Number	K973385
Device Name	Prosthesis, Tendon, Passive
Applicant	TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. DECATUR, GA 30035 US Other 510(k) Applications for this Company
Contact	NORBERT D THOMPSON Other 510(k) Applications for this Contact
Regulation Number	888.3025   More FDA Info for this Regulation Number
Classification Product Code	HXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1997
Decision Date	12/05/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review