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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 K884264
Device Name HIGH RISK NEEDLE CONNECTOR ASSEMBLY
Applicant
Venture Molded Products, Inc.
1405 Lower Ferry Rd.
P.O. Box 7190
Ewing Township,  NJ  08628
Applicant Contact GUSTAV A BORDEN
Correspondent
Venture Molded Products, Inc.
1405 Lower Ferry Rd.
P.O. Box 7190
Ewing Township,  NJ  08628
Correspondent Contact GUSTAV A BORDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/11/1988
Decision Date 11/14/1988
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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