FDA 510(k) Application Details - K925501

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K925501
Device Name	Speculum, Vaginal, Nonmetal
Applicant	ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	TRISH WILLGING Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/1992
Decision Date	06/13/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review