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FDA 510(k) Application Details - K951876
Device Classification Name
Powered Laser Surgical Instrument
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510(K) Number
K951876
Device Name
Powered Laser Surgical Instrument
Applicant
XINTEC CORPORATION
900 ALICE ST.
OAKLAND, CA 94607 US
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Contact
MARILYN M CHOU
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
04/21/1995
Decision Date
03/25/1996
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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