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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 K992079
Device Name KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
Applicant
The Kendall Company, L.P.
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact PAUL W EVANS
Correspondent
The Kendall Company, L.P.
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact PAUL W EVANS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/21/1999
Decision Date 09/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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