INJEX 50 SYSTEM— 510(k) K003864

Substantially Equivalent

Equidyne Systems, Inc.

FDA 510(k) clearance K003864 for INJEX 50 SYSTEM, Substantially Equivalent on 2001-03-06. Applicant: Equidyne Systems, Inc..

Clearance details

Applicant: Equidyne Systems, Inc.
Product code: Code KZE
Advisory panel: General Hospital
Date received: 2000-12-13
Decision date: 2001-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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