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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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More FDA Info for this Product Code
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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