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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K942933
Device Name PRESSURE INFUSION CUFF
Applicant
Circulatory Technology, Inc.
21 Singworth St.
Oyster Bay,  NY  11771
Applicant Contact YEHUDA TAMARI
Correspondent
Circulatory Technology, Inc.
21 Singworth St.
Oyster Bay,  NY  11771
Correspondent Contact YEHUDA TAMARI
Regulation Number880.5420
Classification Product Code
KZD  
Date Received06/22/1994
Decision Date 08/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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