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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 K003864
Device Name INJEX 50 SYSTEM
Applicant
Equidyne Systems, Inc.
11770 Bernardo Plz. Ct.
Suite 351
San Diego,  CA  92128
Applicant Contact JIM BARLEY
Correspondent
Equidyne Systems, Inc.
11770 Bernardo Plz. Ct.
Suite 351
San Diego,  CA  92128
Correspondent Contact JIM BARLEY
Regulation Number880.5430
Classification Product Code
KZE  
Date Received12/13/2000
Decision Date 03/06/2001
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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