FDA 510(k) Application Details - K991563

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K991563
Device Name	Hysteroscope (And Accessories)
Applicant	HENKE SASS WOLF OF AMERICA, INC. 73 EAGLES NEST RD. DUXBURY, MA 02332 US Other 510(k) Applications for this Company
Contact	ELLEN HENKE 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	05/05/1999
Decision Date	10/13/1999
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