FDA 510(k) Application Details - K971979

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K971979
Device Name	Speculum, Vaginal, Nonmetal
Applicant	PLAYTEX PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 PARAMUS, NJ 07652 US Other 510(k) Applications for this Company
Contact	MARK E ROSENGARTEN 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	05/29/1997
Decision Date	09/26/1997
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