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FDA 510(k) Application Details - K221102
Device Classification Name
Instrument, Ultrasonic Surgical
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510(K) Number
K221102
Device Name
Instrument, Ultrasonic Surgical
Applicant
SRA Developments Ltd
Bremridge House
Ashburton TQ13 7JX GB
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Contact
Phillipa Frewin
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LFL
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More FDA Info for this Product Code
Date Received
04/14/2022
Decision Date
12/15/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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