FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIVERSE PARENTERAL NUTRITION BAG
K Number: K891077
·
Decision May 24, 1989
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
9
Review Days
84
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Basic Information
- Device Name
- MEDIVERSE PARENTERAL NUTRITION BAG
- K Number
- K891077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mediflex Intl.
- Date Received
- March 1, 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 Mediflex Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K915140 | PRIMARY DRESSING TRAY | Feb 11, 1992 | Unknown |
| K900841 | HEMODIALYSIS TRANSDUCER PROTECTOR | May 15, 1990 | Substantially Equivalent |
| K884243 | BLOOD TUBING SET | Dec 8, 1988 | Substantially Equivalent |
| K863496 | MEDIFLEX TRANSDUCER PROTECTOR | Sep 23, 1986 | Substantially Equivalent |
| K855039 | MEDIFLEX INJECTION CAP | Jan 24, 1986 | Substantially Equivalent |
| K854346 | MEDIFLEX DISPOSABLE TUBING CLAMP | Nov 18, 1985 | Substantially Equivalent |
| K852106 | I.V. ADMINISTRATION SET | Jun 7, 1985 | Substantially Equivalent |
| K843126 | MEDIFLEX DRAINAGE BAG | Oct 4, 1984 | Substantially Equivalent |