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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K964041
Device Name CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
Applicant
Robert R. Stevens
15720 Bull Run Rd. #377
Miami Lakes,  FL  33014
Applicant Contact MARIAN D HARDING
Correspondent
Robert R. Stevens
15720 Bull Run Rd. #377
Miami Lakes,  FL  33014
Correspondent Contact MARIAN D HARDING
Regulation Number876.5820
Classification Product Code
KOC  
Date Received10/08/1996
Decision Date 01/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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