FDA 510(k) Application Details - K981828

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K981828
Device Name	Hysteroscope (And Accessories)
Applicant	NETOPTIX CORP. 49 PLAIN ST. NORTH ATTLEBORO,, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE, RAC 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	05/22/1998
Decision Date	07/07/1998
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