FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
K Number: K111517
·
Decision Jul 27, 2011
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
52
Applicant Total
3
Review Days
55
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Basic Information
- Device Name
- PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
- K Number
- K111517
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5430
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pharmajet, Inc.
- Date Received
- June 2, 2011
- Decision Date
- July 27, 2011
- Product Code
- KZE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZE | Injector, Fluid, Non-Electrically Powered | FDA class 2 | General Hospital |
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