FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CANNULA, SURGICAL
K Number: K903416
·
Decision Nov 23, 1990
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
10
Review Days
116
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Basic Information
- Device Name
- CANNULA, SURGICAL
- K Number
- K903416
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Advantage Diagnostics Corp.
- Date Received
- July 30, 1990
- Decision Date
- November 23, 1990
- 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 |
Similar 510(k) Clearances
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ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
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DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
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| K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST | Jun 25, 2001 | Substantially Equivalent |
| K003708 | ADVANTAGE THC/COCAINE TEST | Jan 22, 2001 | Substantially Equivalent |
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| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | May 13, 1988 | Substantially Equivalent |