FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
DEPOTONE
K Number: K061032
·
Decision Jun 21, 2006
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
2
Review Days
68
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Basic Information
- Device Name
- DEPOTONE
- K Number
- K061032
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imprint Pharmaceuticals Limited
- Date Received
- April 14, 2006
- Decision Date
- June 21, 2006
- 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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Other Clearances by Imprint Pharmaceuticals Limited
| K Number | Device Name | ||
|---|---|---|---|
| K050505 | DEPOTONE | Apr 5, 2005 | Substantially Equivalent |