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FDA 510(k) Application Details - K023464
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K023464
Device Name
Powered Laser Surgical Instrument
Applicant
QUANTEL MEDICAL
342 SUNSET BAY RD.
HOT SPRINGS, AR 71913 US
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Contact
ROGER W BARNES
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
10/15/2002
Decision Date
01/13/2003
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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