FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PBC NEEDLE BY NIPRO MED. INDUSTRIES
K Number: K820911
·
Decision Apr 15, 1982
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
11
Review Days
14
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Basic Information
- Device Name
- PBC NEEDLE BY NIPRO MED. INDUSTRIES
- K Number
- K820911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Philadelphia Biologics Center
- Date Received
- April 1, 1982
- Decision Date
- April 15, 1982
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Philadelphia Biologics Center
| K Number | Device Name | ||
|---|---|---|---|
| K841717 | INTRAVENOUS INJECTION SET | Jul 23, 1984 | Substantially Equivalent |
| K834256 | PBC SYRINGE IRRIGATING | Mar 23, 1984 | Substantially Equivalent |
| K834255 | PBC SCALP VEIN SET | Mar 12, 1984 | Substantially Equivalent |
| K834254 | PBC IV SET VENTED | Feb 27, 1984 | Substantially Equivalent |
| K834252 | PBC EXTENSION SET | Feb 27, 1984 | Substantially Equivalent |
| K834253 | PBC IV SET NON-VENTED | Feb 27, 1984 | Substantially Equivalent |
| K813649 | PBC NEEDLE | Jan 28, 1982 | Substantially Equivalent |
| K813646 | JMS DISPOSABLE SYRINGE | Jan 28, 1982 | Substantially Equivalent |
| K813648 | JMS NEEDLE & MAC JECT | Jan 28, 1982 | Substantially Equivalent |
| K813647 | PBC SYRINGE | Jan 25, 1982 | Substantially Equivalent |