FDA 510(k) Application Details - K952186

Device Classification Name Hysteroscope (And Accessories)

  More FDA Info for this Device
510(K) Number K952186
Device Name Hysteroscope (And Accessories)
Applicant HENKE-SASS WOLF, GMBH.
POSTFACH 2459
TUTTLINGEN 78507 DE
Other 510(k) Applications for this Company
Contact ARMIN LEKITSCH
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 05/09/1995
Decision Date 02/06/1996
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact