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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K873309
Device Name REFLEX(TM) CA-T CLIP APPLIER
Applicant
RICHARD-ALLAN MEDICAL IND., INC.
8850 M89
BOX 351
RICHLAND,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
RICHARD-ALLAN MEDICAL IND., INC.
8850 M89
BOX 351
RICHLAND,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number878.4300
Classification Product Code
FZP  
Date Received08/18/1987
Decision Date 11/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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