FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUTRISAFE ENTERAL FEEDING TUBE
K Number: K981629
·
Decision Feb 4, 1999
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
15
Review Days
273
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Basic Information
- Device Name
- NUTRISAFE ENTERAL FEEDING TUBE
- K Number
- K981629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schiff & Co.
- Date Received
- May 7, 1998
- Decision Date
- February 4, 1999
- 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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| K943521 | VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE | Feb 14, 1995 | Substantially Equivalent |
| K896684 | KEMBLE LIQUID HANDLING SYSTEM DISPENSER | Apr 16, 1990 | Substantially Equivalent |
| K894617 | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL | Oct 31, 1989 | Substantially Equivalent |