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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spatula, surgical, general & plastic surgery
510(k) Number K023688
Device Name LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
Applicant
LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON,  MA  01803
Applicant Contact JAMES ASHBY
Correspondent
LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON,  MA  01803
Correspondent Contact JAMES ASHBY
Regulation Number878.4800
Classification Product Code
GAF  
Date Received11/01/2002
Decision Date 01/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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