FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOURNIQUET
K Number: K851482
·
Decision Apr 29, 1985
Classifications
1
FEI Numbers
335
Registration Numbers
335
Same Product Code
19
Applicant Total
23
Review Days
14
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Basic Information
- Device Name
- TOURNIQUET
- K Number
- K851482
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Polymer Technology Corp.
- Date Received
- April 15, 1985
- Decision Date
- April 29, 1985
- Product Code
- GAX
- 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 |
|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAX), ordered by most recent decision date.
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UNIVERSAL TOURNIQUET
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KINDERWRAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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