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FDA 510(k) Application Details - K963991
Device Classification Name
Powered Laser Surgical Instrument
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510(K) Number
K963991
Device Name
Powered Laser Surgical Instrument
Applicant
FULL SPECTRUM, INC.
2515 ELWOOD DR., SUITE 108
AMES, IA 50010 US
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Contact
GERALD J SHIRK, M.D.
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
10/04/1996
Decision Date
04/24/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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