FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EZ VEIN INFLATABLE TOURNIQUET
K Number: K112874
·
Decision Oct 17, 2011
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
33
Applicant Total
1
Review Days
17
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Basic Information
- Device Name
- EZ VEIN INFLATABLE TOURNIQUET
- K Number
- K112874
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dominion Medical Devices, LLC
- Date Received
- September 30, 2011
- Decision Date
- October 17, 2011
- Product Code
- KCY
- 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 |
|---|---|---|---|
| KCY | Tourniquet, Pneumatic | FDA class 1 | General, Plastic Surgery |
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