FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
E.N.S.I. RETRACTABLE SAFETY SYRINGE
K Number: K003348
·
Decision Jan 12, 2001
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
1
Review Days
78
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Basic Information
- Device Name
- E.N.S.I. RETRACTABLE SAFETY SYRINGE
- K Number
- K003348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ensi-Med International Pty. , Ltd.
- Date Received
- October 26, 2000
- Decision Date
- January 12, 2001
- Product Code
- MEG
- 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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