HYPEX(TM) JET INJECTOR— 510(k) K945873
Substantially EquivalentEquidyne Systems, Inc.
FDA 510(k) clearance K945873 for HYPEX(TM) JET INJECTOR, Substantially Equivalent on 1995-08-18. Applicant: Equidyne Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Equidyne Systems, Inc.
- Product code
- Code KZE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
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