FDA 510(k) Application Details - K053583

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K053583
Device Name	Hysteroscope (And Accessories)
Applicant	OPTIVIA MEDICAL LLC 101 N. CHESTNUT STREET SUITE 305 WINSTON-SALEM, NC 27101 US Other 510(k) Applications for this Company
Contact	ROBERT M KELLEY Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2005
Decision Date	03/31/2006
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