FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
K Number: K970370
·
Decision Apr 10, 1997
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
- K Number
- K970370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tsk Laboratory, Japan
- Date Received
- January 31, 1997
- Decision Date
- April 10, 1997
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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