FDA 510(k) Application Details - K031436

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K031436
Device Name	Colposcope (And Colpomicroscope)
Applicant	SOMETECH CORPORATION 6669 PEACHTREE INDUSTRIAL BLVD SUITE J NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	KI CHEOL HAN Other 510(k) Applications for this Contact
Regulation Number	884.1630   More FDA Info for this Regulation Number
Classification Product Code	HEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2003
Decision Date	12/19/2003
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