FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
DEDO SUCTION CANNULA
K Number: K854005
·
Decision Dec 6, 1985
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
1
Review Days
67
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Basic Information
- Device Name
- DEDO SUCTION CANNULA
- K Number
- K854005
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Dedo Manufacturer, Inc.
- Date Received
- September 30, 1985
- Decision Date
- December 6, 1985
- Product Code
- GEA
- 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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