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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K946084
Device Name VANGUARD
Applicant
Vanguard Container Corp.
35 Cotters Ln.
East Brunswick,  NJ  08816
Applicant Contact ENID ROKAW
Correspondent
Vanguard Container Corp.
35 Cotters Ln.
East Brunswick,  NJ  08816
Correspondent Contact ENID ROKAW
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/13/1994
Decision Date 05/17/1995
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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