FDA 510(k) Application Details - K984211

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K984211
Device Name	Speculum, Vaginal, Nonmetal
Applicant	MEDSCAND AB P.O. BOX 20047 MALMO 520074 SE Other 510(k) Applications for this Company
Contact	TENNY P TSE 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	11/24/1998
Decision Date	12/23/1998
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