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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K851293
Device Name IMPLANTOFIX
Applicant
Burron Medical Products, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact TRACEY YAKABOW
Correspondent
Burron Medical Products, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact TRACEY YAKABOW
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/01/1985
Decision Date 01/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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