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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K945592
Device Name VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE
Applicant
Vlv Associates, Inc.
30-C Ridgedale Ave.
East Hanover,  NJ  07936
Applicant Contact VINCENT L VAILANCOURT
Correspondent
Vlv Associates, Inc.
30-C Ridgedale Ave.
East Hanover,  NJ  07936
Correspondent Contact VINCENT L VAILANCOURT
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/14/1994
Decision Date 07/14/1995
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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