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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 K083482
Device Name COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
Applicant
Cook Vascular, Inc.
1186 Montgomery Ln.
Vandergrift,  PA  15690
Applicant Contact JIM FERGUSON, JR.
Correspondent
Cook Vascular, Inc.
1186 Montgomery Ln.
Vandergrift,  PA  15690
Correspondent Contact JIM FERGUSON, JR.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/24/2008
Decision Date 04/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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