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 K935862
Device Name NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
Applicant
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact ROBERT R MANTELL
Correspondent
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact ROBERT R MANTELL
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/03/1993
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-