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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 K062914
Device Name HEM-O-LOK LIGATION CLIP
Applicant
Teleflex Medical
2345 Waukegan Rd.
Bannockburn,  IL  60015
Applicant Contact LORI HAYS
Correspondent
Teleflex Medical
2345 Waukegan Rd.
Bannockburn,  IL  60015
Correspondent Contact LORI HAYS
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/27/2006
Decision Date 11/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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