FDA 510(k) Application Details - K021153

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K021153
Device Name	Colposcope (And Colpomicroscope)
Applicant	GOLDWAY US, INC. 12 SOUTH FIRST STREET, SUITE 1205 SAN JOSE, CA 95113 US Other 510(k) Applications for this Company
Contact	Y. JUSTIN CHEN 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	04/10/2002
Decision Date	02/10/2003
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