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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
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