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FDA 510(k) Application Details - K230621
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K230621
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Surgical Principals, Inc.
1625 South Tacoma Way
Tacoma, WA 98409 US
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Contact
Timothy Wynne
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
03/06/2023
Decision Date
12/01/2023
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
FDA Source Information for K230621
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