FDA 510(k) Application Details - K973853

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K973853
Device Name	Speculum, Vaginal, Nonmetal
Applicant	KOLPLAST COMERCIAL E INDUSTRIAL LTDA P.O BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E J SMITH 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	10/08/1997
Decision Date	12/19/1997
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