FDA 510(k) Application Details - K942032

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K942032
Device Name	Plate, Fixation, Bone
Applicant	HOSPITAL FOR SPECIAL SURGERY 535 EAST 70TH ST. NEW YORK, NY 10021 US Other 510(k) Applications for this Company
Contact	BRUCE H ROBIE Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/1994
Decision Date	06/13/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review