FDA 510(k) Application Details - K961555

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K961555
Device Name	Staple, Fixation, Bone
Applicant	ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	AMY WALTERS 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	04/22/1996
Decision Date	07/10/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review