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 Lithotriptor, Biliary Mechanical
510(k) Number K911364
Device Name SPOON FORCEPS, 11MM
Applicant
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Applicant Contact SAMUELLA D EMRICH
Correspondent
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Correspondent Contact SAMUELLA D EMRICH
Regulation Number876.4500
Classification Product Code
LQC  
Date Received03/28/1991
Decision Date 10/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-