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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 K051985
Device Name BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
Applicant
Biovalve Technologies, Inc.
155 Flanders Rd.
Westborough,  MA  01581
Applicant Contact SCOTT HUIE
Correspondent
Biovalve Technologies, Inc.
155 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact SCOTT HUIE
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/22/2005
Decision Date 08/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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