FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEONATAL FEEDING KIT
K Number: K864683
·
Decision Apr 17, 1987
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
8
Review Days
136
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Basic Information
- Device Name
- NEONATAL FEEDING KIT
- K Number
- K864683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Salt Creek Medical Technologies
- Date Received
- December 2, 1986
- Decision Date
- April 17, 1987
- 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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ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
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Other Clearances by Salt Creek Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K871042 | URINE METER, 250CC | Mar 25, 1987 | Substantially Equivalent |
| K871075 | SCMT UMBILICAL CLAMP | Mar 23, 1987 | Substantially Equivalent |
| K871087 | S.C.M.T. PERFORATOR | Mar 23, 1987 | Substantially Equivalent |
| K864296 | S.C.T. MULTI PORT, INJECTION SITE | Mar 2, 1987 | Substantially Equivalent |
| K864682 | SALT CREEK P.I. TRAY | Jan 6, 1987 | Substantially Equivalent |
| K864692 | EXTENSION SETS | Dec 18, 1986 | Substantially Equivalent |
| K864693 | I.V. START KITS | Dec 16, 1986 | Substantially Equivalent |