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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 K993424
Device Name THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
Applicant
Y-Clip Associates
116 Defense Highway
Annapolis,  MD  21401
Applicant Contact GEORGE YU
Correspondent
Y-Clip Associates
116 Defense Highway
Annapolis,  MD  21401
Correspondent Contact GEORGE YU
Regulation Number878.4300
Classification Product Code
FZP  
Date Received10/12/1999
Decision Date 12/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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