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FDA 510(k) Application Details - K182653
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K182653
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact
Andrew Nguyen
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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
09/25/2018
Decision Date
11/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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