FDA 510(k) Application Details - K991588

Device Classification Name	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment   More FDA Info for this Device
510(K) Number	K991588
Device Name	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Applicant	(EMS SA) ELECTRO MEDICAL SYSTEMS 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	SHEILA HAMEON-HEYER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	HSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/1999
Decision Date	07/21/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review