Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name insufflator, hysteroscopic
510(k) Number K922632
Device Name WOM HYSTEROFLATOR OP
Applicant
W.O.M. GMBH
PASCALSTRABE 11
BERLIN,  DE D-10587
Applicant Contact OWEN LAMB
Correspondent
W.O.M. GMBH
PASCALSTRABE 11
BERLIN,  DE D-10587
Correspondent Contact OWEN LAMB
Regulation Number884.1700
Classification Product Code
HIG  
Date Received03/04/1992
Decision Date 03/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-