FDA 510(k) Application Details - K982156

Device Classification Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained   More FDA Info for this Device
510(K) Number	K982156
Device Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant	PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	LINDA K DILLON Other 510(k) Applications for this Contact
Regulation Number	888.3800   More FDA Info for this Regulation Number
Classification Product Code	JWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/1998
Decision Date	07/29/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review