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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K933364
Device Name PROMED BIOPSY NEEDLE
Applicant
Vlv Associates, Inc.
30c Ridgedale Ave.
East Hanover,  NJ  07936
Applicant Contact VINCENT L VAILLANCOURT
Correspondent
Vlv Associates, Inc.
30c Ridgedale Ave.
East Hanover,  NJ  07936
Correspondent Contact VINCENT L VAILLANCOURT
Regulation Number878.4800
Classification Product Code
DWO  
Date Received07/09/1993
Decision Date 02/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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