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FDA 510(k) Application Details - K213761
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K213761
Device Name
Powered Laser Surgical Instrument
Applicant
Sciton, Inc
925 Commercial Street
Palo Alto, CA 94303 US
Other 510(k) Applications for this Company
Contact
Jay M Patel
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
12/01/2021
Decision Date
07/19/2022
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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