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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 K863581
Device Name MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact MARK W WENZEL
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact MARK W WENZEL
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/15/1986
Decision Date 10/31/1986
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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