FDA 510(k) Application Details - K954443

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K954443
Device Name	Staple, Fixation, Bone
Applicant	POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	MARY VERSTYNEN Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/1995
Decision Date	01/31/1996
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