FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORICARE L2700
K Number: K122875
·
Decision Dec 18, 2012
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- ORICARE L2700
- K Number
- K122875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oricare, Inc.
- Date Received
- September 19, 2012
- Decision Date
- December 18, 2012
- Product Code
- FSY
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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