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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Elastomeric
510(k) Number K940406
Device Name DISPOSABLE, AMBULATORY, INFUSION PUMPS
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 Number880.5725
Classification Product Code
MEB  
Date Received01/27/1994
Decision Date 09/02/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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