FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
L1-PRO SYSTEM
K Number: K041665
·
Decision Jul 23, 2004
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
2
Review Days
35
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Basic Information
- Device Name
- L1-PRO SYSTEM
- K Number
- K041665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pelikan Technologies, Inc.
- Date Received
- June 18, 2004
- Decision Date
- July 23, 2004
- Product Code
- FMK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Pelikan Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K024170 | L1 SYSTEM | Apr 14, 2003 | Substantially Equivalent |