FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROGUARD(TM) BLOOD COLLECTION NEEDLE
K Number: K904295
·
Decision Oct 15, 1990
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
2
Review Days
26
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Basic Information
- Device Name
- PROGUARD(TM) BLOOD COLLECTION NEEDLE
- K Number
- K904295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Safety-Ject, Inc.
- Date Received
- September 19, 1990
- Decision Date
- October 15, 1990
- 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 Safety-Ject, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896086 | PROGUARD II(TM) | Jan 24, 1990 | Substantially Equivalent |