FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
K Number: K071140
·
Decision Jun 7, 2007
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
33
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
- K Number
- K071140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Top Spins, Inc.
- Date Received
- April 24, 2007
- Decision Date
- June 7, 2007
- Product Code
- KCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KCY | Tourniquet, Pneumatic | FDA class 1 | General, Plastic Surgery |
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