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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 K862404
Device Name REFLEX(TM) CLIP APPLIER
Applicant
Richard-Allan Medical Ind., Inc.
8850m89, Box 351
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Richard-Allan Medical Ind., Inc.
8850m89, Box 351
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number878.4300
Classification Product Code
FZP  
Date Received06/25/1986
Decision Date 07/23/1986
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
Predetermined Change
Control Plan Authorized		 No
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