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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K010888
Device Name SIDEPORT PINCH CLAMP DEVICE
Applicant
Medivice Systems, Ltd.
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Medivice Systems, Ltd.
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/23/2001
Decision Date 06/27/2001
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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