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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Vein, External
510(k) Number K212894
Device Name PhasTIPP
Applicant
LeMaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Applicant Contact Anurag Gadgil
Correspondent
LeMaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Correspondent Contact Anurag Gadgil
Regulation Number870.4885
Classification Product Code
DWQ  
Date Received09/10/2021
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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