FDA 510(k) Application Details - K971507

Device Classification Name	Chamber, Oxygen, Topical, Extremity   More FDA Info for this Device
510(K) Number	K971507
Device Name	Chamber, Oxygen, Topical, Extremity
Applicant	GWR MEDICAL, LLP 124 COMMONS COURT CHADDS FORD, PA 19317 US Other 510(k) Applications for this Company
Contact	JOSEPH R WESTWOOD Other 510(k) Applications for this Contact
Regulation Number	878.5650   More FDA Info for this Regulation Number
Classification Product Code	KPJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/1997
Decision Date	11/07/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review