FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGIFEED
K Number: K791714
·
Decision Jan 16, 1980
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
5
Review Days
139
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Basic Information
- Device Name
- SURGIFEED
- K Number
- K791714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Health Development Corp.
- Date Received
- August 30, 1979
- Decision Date
- January 16, 1980
- 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 Health Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K830397 | PEM-C | Apr 12, 1983 | Substantially Equivalent |
| K823937 | SEMINAL COLLECTION DEVICE | Feb 24, 1983 | Substantially Equivalent |
| K810499 | PERCUTANEOUS GASTROINTESTINAL TUBE | Mar 4, 1981 | Substantially Equivalent |
| K802482 | KEOFEED (R) EASY-FILL ENTERIC FEED BAG | Oct 31, 1980 | Substantially Equivalent |