FDA 510(k) Application Details - K072762

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K072762
Device Name	Speculum, Vaginal, Nonmetal
Applicant	DEPALT INC. 5013 STONEWICK COURT PLANO, TX 75093 US Other 510(k) Applications for this Company
Contact	RAJEEV PATEL 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	09/28/2007
Decision Date	01/22/2008
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