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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 K852361
Device Name INTRAVENOUS INJECTION SET
Applicant
The West Co., Inc.
Cemetery & Oliver St.
Jersey Shore,  PA  17740
Applicant Contact GEORGE ALBRECHT
Correspondent
The West Co., Inc.
Cemetery & Oliver St.
Jersey Shore,  PA  17740
Correspondent Contact GEORGE ALBRECHT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/04/1985
Decision Date 07/16/1985
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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