FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
NELATON-, FEMALE - OR TIEMANN CATHETER
K Number: K896729
·
Decision Nov 5, 1990
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
7
Review Days
340
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Basic Information
- Device Name
- NELATON-, FEMALE - OR TIEMANN CATHETER
- K Number
- K896729
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Unoplast A/S
- Date Received
- November 30, 1989
- Decision Date
- November 5, 1990
- Product Code
- KOD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Unoplast A/S
| K Number | Device Name | ||
|---|---|---|---|
| K896734 | FEEDING TUBE | Dec 21, 1990 | Substantially Equivalent |
| K896732 | UNOMETER 500 | Nov 2, 1990 | Substantially Equivalent |
| K896731 | OXYGEN CATHETERS | Mar 30, 1990 | Substantially Equivalent |
| K896730 | SUCTION CATHETER STRAIGHT/COUDE | Mar 30, 1990 | Substantially Equivalent |
| K896733 | VACCON | Feb 1, 1990 | Substantially Equivalent |
| K802248 | DISARP ORIGINAL | Sep 26, 1980 | Substantially Equivalent |