FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
K Number: K890095
·
Decision May 24, 1989
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
12
Review Days
134
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Basic Information
- Device Name
- PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
- K Number
- K890095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- January 10, 1989
- Decision Date
- May 24, 1989
- Product Code
- KPE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Kells Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926333 | CPR PLUS | Nov 8, 1993 | Substantially Equivalent |
| K890093 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET | Jul 24, 1989 | Substantially Equivalent |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K844463 | DERMIDRESS | Jan 8, 1985 | Substantially Equivalent |
| K844072 | DERMIZIP SKIN CLOSURE DEVICE | Nov 5, 1984 | Substantially Equivalent |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Mar 7, 1984 | Substantially Equivalent |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Sep 29, 1983 | Substantially Equivalent |
| K823118 | SAY | Jan 7, 1983 | Substantially Equivalent |
| K823226 | SN-100 DOCTOR'S ROUND | Nov 22, 1982 | Substantially Equivalent |