FDA 510(k) Application Details - K990067

Device Classification Name	Barrier,Std,Oral Sex   More FDA Info for this Device
510(K) Number	K990067
Device Name	Barrier,Std,Oral Sex
Applicant	LOUISE C. MYERS 14808 N.E. 66TH ST. REDMOND, 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	01/08/1999
Decision Date	02/19/1999
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