FDA 510(k) Application Details - K963777

Device Classification Name	Chamber, Oxygen, Topical, Extremity   More FDA Info for this Device
510(K) Number	K963777
Device Name	Chamber, Oxygen, Topical, Extremity
Applicant	STEPHENSON INDUSTRIES, INC. 1648 BEAVER DAM RD. POINT PLEASANT, NJ 08742 US Other 510(k) Applications for this Company
Contact	R A LASHLY 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	09/20/1996
Decision Date	07/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review