FDA 510(k) Application Details - K992736

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K992736
Device Name	Speculum, Vaginal, Nonmetal
Applicant	WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. ORANGE, CT 06477 US Other 510(k) Applications for this Company
Contact	MICHAEL MALIS 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	08/13/1999
Decision Date	09/29/1999
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