FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIOUS TUBING
K Number: K943206
·
Decision Mar 9, 1995
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
63
Applicant Total
7
Review Days
247
Basic Information
- Device Name
- VARIOUS TUBING
- K Number
- K943206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PRN SERVICES, INC.
- Date Received
- July 5, 1994
- Decision Date
- March 9, 1995
- Product Code
- FPK
- 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 |
|---|---|---|---|
| FPK | Tubing, Fluid Delivery | FDA class 2 | General Hospital |
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Other Clearances by PRN SERVICES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K902330 | E-Z FLO + SET | Sep 21, 1990 | Substantially Equivalent |
| K897065 | PORT INFUSION SET (PIS) INFUSION SET (IS) | Feb 16, 1990 | Substantially Equivalent |
| K882598 | 250 ML BAG W/Y INJECT. & 12 EXTENSION SET | Nov 1, 1988 | Substantially Equivalent |
| K884053 | PRN PLUS + INFUSION SET | Oct 31, 1988 | Substantially Equivalent |
| K875155 | 60 ML RESERVOIR BAG, ITEM #200 | Feb 16, 1988 | Substantially Equivalent |
| K860222 | 70 ML RESERVOIR BAG AND ADMINISTRATION SETS | Jun 9, 1986 | Substantially Equivalent |