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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 K052018
Device Name MILTEX LIGATING CLIP
Applicant
MILTEX, INC.
589 DAVIES DRIVE
YORK,  PA  17402
Applicant Contact CHARLES WEAVER
Correspondent
MILTEX, INC.
589 DAVIES DRIVE
YORK,  PA  17402
Correspondent Contact CHARLES WEAVER
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/26/2005
Decision Date 11/04/2005
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
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