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FDA 510(k) Application Details - K023688
Device Classification Name
Spatula, Surgical, General & Plastic Surgery
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510(K) Number
K023688
Device Name
Spatula, Surgical, General & Plastic Surgery
Applicant
LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON, MA 01803 US
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Contact
JAMES ASHBY
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
GAF
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More FDA Info for this Product Code
Date Received
11/01/2002
Decision Date
01/30/2003
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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