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FDA 510(k) Application Details - K200104
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K200104
Device Name
Powered Laser Surgical Instrument
Applicant
RAJA Trading Company, Inc.
801 South Olive Avenue, Suite 124
West Palm Beach, FL 33401 US
Other 510(k) Applications for this Company
Contact
Robert J Adipietro
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/17/2020
Decision Date
06/04/2020
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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