FDA 510(k) Application Details - K012869

Device Classification Name Hysteroscope (And Accessories)

  More FDA Info for this Device
510(K) Number K012869
Device Name Hysteroscope (And Accessories)
Applicant GIMMI GMBH
AMSTEL 320-I
AMSTERDAM 1017AP NL
Other 510(k) Applications for this Company
Contact DAGMAR MASER
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 08/27/2001
Decision Date 03/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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