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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 K092761
Device Name PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
Applicant
Bio Protech, Inc.
2626 Valley View Ln.,
Suite 4
Dallas,  TX  75234
Applicant Contact JUDY BURTON
Correspondent
Bio Protech, Inc.
2626 Valley View Ln.,
Suite 4
Dallas,  TX  75234
Correspondent Contact JUDY BURTON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/09/2009
Decision Date 11/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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