FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERAL FEEDING TUBE
K Number: K890116
·
Decision Apr 5, 1989
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
30
Review Days
84
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Basic Information
- Device Name
- ENTERAL FEEDING TUBE
- K Number
- K890116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hdc Corp.
- Date Received
- January 11, 1989
- Decision Date
- April 5, 1989
- 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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| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Mar 15, 2001 | Substantially Equivalent |
| K994059 | CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 | Oct 13, 2000 | Substantially Equivalent |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Sep 26, 2000 | Substantially Equivalent |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Mar 15, 1999 | Substantially Equivalent |