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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sleeve, limb, compressible
510(k) Number K781357
Device Name T.E.D. SEQUENTIAL COMPRESSION SLEEVES
Applicant
KENDALL RESEARCH CENTER
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KENDALL RESEARCH CENTER
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/08/1978
Decision Date 09/20/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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