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 Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K954377
Device Name FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC
Applicant
ANNEX MEDICAL, INC.
7098 SHADY OAK RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact EUGENE C KARLES
Correspondent
ANNEX MEDICAL, INC.
7098 SHADY OAK RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact EUGENE C KARLES
Regulation Number876.4680
Classification Product Code
FFL  
Date Received09/19/1995
Decision Date 10/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-