FDA 510(k) Application Details - K970577

Device Classification Name	Barrier,Std,Oral Sex   More FDA Info for this Device
510(K) Number	K970577
Device Name	Barrier,Std,Oral Sex
Applicant	GLYDE USA, INC. 14808 N.E. 66TH ST. REMOND, WA 98052-4712 US Other 510(k) Applications for this Company
Contact	LOUISE C MYERS Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	MSC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/1997
Decision Date	01/08/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review