FDA 510(k) Application Details - K073360

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K073360
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BIO PROTECH, INC.
1676 VILLAGE GREEN SUITE A
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 11/30/2007
Decision Date 12/19/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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