FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON CALL CHOSEN LANCING DEVICE
K Number: K113332
·
Decision Apr 18, 2012
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
105
Applicant Total
68
Review Days
156
Basic Information
- Device Name
- ON CALL CHOSEN LANCING DEVICE
- K Number
- K113332
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON LABORATORIES, INC.
- Date Received
- November 14, 2011
- Decision Date
- April 18, 2012
- 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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