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FDA 510(k) Application Details - K171391
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K171391
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
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Contact
Ben Krebs
Other 510(k) Applications for this Contact
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
05/11/2017
Decision Date
01/26/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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