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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, Surgical
510(k) Number K912548
Device Name LEMAITRE-BOOKWALTER VESSEL DEVICES
Applicant
Vascutech, Inc.
140 Haverhill St.
Andover,  MA  01810
Applicant Contact LISA A PARE
Correspondent
Vascutech, Inc.
140 Haverhill St.
Andover,  MA  01810
Correspondent Contact LISA A PARE
Regulation Number870.4475
Classification Product Code
DWP  
Date Received06/10/1991
Decision Date 09/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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