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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K895098
Device Name BIOPSY FORCEPS
Applicant
Annex Medical, Inc.
7887 Fuller Rd. #109
Eden Prairie,  MN  55344
Applicant Contact STUART LIND
Correspondent
Annex Medical, Inc.
7887 Fuller Rd. #109
Eden Prairie,  MN  55344
Correspondent Contact STUART LIND
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received08/15/1989
Decision Date 10/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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