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, Laparoscopic
510(k) Number K921264
Device Name SURGIFLATOR
Applicant
W.O.M. World of Medicine GmbH
8536 Calle Tioga
Tucson,  AR  85704
Applicant Contact OWEN B LAMB
Correspondent
W.O.M. World of Medicine GmbH
8536 Calle Tioga
Tucson,  AR  85704
Correspondent Contact OWEN B LAMB
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/16/1992
Decision Date 10/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-