FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
DEGANIA SILICONE TOURNIQUET
K Number: K875092
·
Decision Jan 7, 1988
Classifications
1
FEI Numbers
335
Registration Numbers
335
Same Product Code
19
Applicant Total
19
Review Days
28
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Basic Information
- Device Name
- DEGANIA SILICONE TOURNIQUET
- K Number
- K875092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Degania Silicone , Ltd.
- Date Received
- December 10, 1987
- Decision Date
- January 7, 1988
- 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
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DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
FDA 510(k)
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