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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K896293
Device Name VIRAFREE CORP. EJECTABLE NEEDLE HOLDER
Applicant
Virafree Corp.
107 Browne St.
Brookline,  MA  02146
Applicant Contact HABIB A SIOUFI
Correspondent
Virafree Corp.
107 Browne St.
Brookline,  MA  02146
Correspondent Contact HABIB A SIOUFI
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/31/1989
Decision Date 01/18/1990
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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