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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Non-Electric
510(k) Number K952863
Device Name FORCEPS, BIOPSY, NON-ELECTRIC
Applicant
Annex Medical, Inc.
7098 Shady Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact EUGENE C KARELS
Correspondent
Annex Medical, Inc.
7098 Shady Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact EUGENE C KARELS
Regulation Number876.1075
Classification Product Code
FCL  
Date Received06/22/1995
Decision Date 07/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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