FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIETO CONTAINER FOR ENTERNAL NUTRIT
K Number: K840916
·
Decision Apr 4, 1984
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
7
Review Days
35
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Basic Information
- Device Name
- DIETO CONTAINER FOR ENTERNAL NUTRIT
- K Number
- K840916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gil-Med Industries C/O Kegan & Kegan, Ltd.
- Date Received
- February 29, 1984
- Decision Date
- April 4, 1984
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Gil-Med Industries C/O Kegan & Kegan, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K880506 | MODIFIED EVA-MIX AND DI-MIX BAGS | May 20, 1988 | Substantially Equivalent |
| K870274 | DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER | Feb 10, 1987 | Substantially Equivalent |
| K861862 | DIETO CONTAINER FOR ENTERAL NUTRITION | Aug 11, 1986 | Substantially Equivalent |
| K841597 | GIL-MED PARENTERAL NUTRITION OR MEDICINE | Oct 26, 1984 | Substantially Equivalent |
| K841224 | URO-MALE INCONTINENCE CATHETER | May 2, 1984 | Substantially Equivalent |
| K840915 | DIMIX CONTAINER FOR PARNETERAL NUTRIT | Apr 17, 1984 | Substantially Equivalent |