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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 K972957
Device Name SA-EF MULTI-LUMEN EXTENSION SET
Applicant
Vlv Associates, Inc.
30-C Ridgedale Ave.
East Hanover,  NJ  07936
Applicant Contact VINCENT VAILLANCOURT
Correspondent
Vlv Associates, Inc.
30-C Ridgedale Ave.
East Hanover,  NJ  07936
Correspondent Contact VINCENT VAILLANCOURT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/11/1997
Decision Date 09/29/1997
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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