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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 K945873
Device Name HYPEX(TM) JET INJECTOR
Applicant
Equidyne Systems, Inc.
924 Calle Negocio, Suite A
San Clemente,  CA  92673
Applicant Contact JAMES BARLEY
Correspondent
Equidyne Systems, Inc.
924 Calle Negocio, Suite A
San Clemente,  CA  92673
Correspondent Contact JAMES BARLEY
Regulation Number880.5430
Classification Product Code
KZE  
Date Received12/01/1994
Decision Date 08/18/1995
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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