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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K073360
Device Name PROPLATE
Applicant
Bio Protech, Inc.
1676 Village Green Suite A
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF RONGERO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/30/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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