FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
FEEDING TUBE
K Number: K896734
·
Decision Dec 21, 1990
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
7
Review Days
386
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Basic Information
- Device Name
- FEEDING TUBE
- K Number
- K896734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Unoplast A/S
- Date Received
- November 30, 1989
- Decision Date
- December 21, 1990
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
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Other Clearances by Unoplast A/S
| K Number | Device Name | ||
|---|---|---|---|
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER | Nov 5, 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 |