FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO-JECT(TM) SAFETY NEEDLE HOLDER
K Number: K892665
·
Decision Oct 4, 1989
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
6
Review Days
174
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Basic Information
- Device Name
- PRO-JECT(TM) SAFETY NEEDLE HOLDER
- K Number
- K892665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pro-Tec Containers, Inc.
- Date Received
- April 13, 1989
- Decision Date
- October 4, 1989
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Pro-Tec Containers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945276 | PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G | Dec 14, 1994 | Substantially Equivalent |
| K945274 | PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 | Dec 14, 1994 | Substantially Equivalent |
| K945275 | PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1 | Dec 14, 1994 | Substantially Equivalent |
| K945273 | PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2 | Dec 14, 1994 | Substantially Equivalent |
| K942179 | PRO-TEC DISPOSABLE SHARPS CONTAINERS | Dec 2, 1994 | Substantially Equivalent |