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 K934866
Device Name HYS-SURGIMAT
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
1300 I STREET, N.W.
SUITE 900 WEST
WASHIGNTON,  DC  20005 -3306
Applicant Contact E KEEFER
Correspondent
W.O.M. WORLD OF MEDICINE, GMBH
1300 I STREET, N.W.
SUITE 900 WEST
WASHIGNTON,  DC  20005 -3306
Correspondent Contact E KEEFER
Regulation Number884.1700
Classification Product Code
HIG  
Date Received10/12/1993
Decision Date 10/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-