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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K041691
Device Name CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
Applicant
West Pharmaceutical Services, Inc.
101 Gordon Dr.
Lionville,  PA  19341
Applicant Contact DAVID WEISER
Correspondent
West Pharmaceutical Services, Inc.
101 Gordon Dr.
Lionville,  PA  19341
Correspondent Contact DAVID WEISER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/22/2004
Decision Date 08/05/2004
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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