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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Thigh/Knee/Shank/Ankle/Foot, External
510(k) Number K932184
Device Name STERILE LEMAITRE GLOW 'N TELL TAPE
Applicant
Vascutech, Inc.
790 Turnpike St.
North Andover,  MA  01845
Applicant Contact GEORGE LEMAITRE
Correspondent
Vascutech, Inc.
790 Turnpike St.
North Andover,  MA  01845
Correspondent Contact GEORGE LEMAITRE
Regulation Number890.3500
Classification Product Code
KFX  
Date Received05/05/1993
Decision Date 07/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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