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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K032976
Device Name BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
Applicant
Biovalve Technologies, Inc.
One Innovation Dr.
3 Biotech
Worcester,  MA  01605
Applicant Contact SCOTT HUIE
Correspondent
Biovalve Technologies, Inc.
One Innovation Dr.
3 Biotech
Worcester,  MA  01605
Correspondent Contact SCOTT HUIE
Regulation Number880.5430
Classification Product Code
KZE  
Date Received09/24/2003
Decision Date 04/16/2004
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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