FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFETY INFUSION SET
K Number: K080235
·
Decision Apr 24, 2008
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
85
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Basic Information
- Device Name
- SAFETY INFUSION SET
- K Number
- K080235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Greiner Bio-One Vacuette North America
- Date Received
- January 30, 2008
- Decision Date
- April 24, 2008
- 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 Greiner Bio-One Vacuette North America
| K Number | Device Name | ||
|---|---|---|---|
| K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | Apr 15, 2005 | Substantially Equivalent |
| K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | Dec 29, 2003 | Substantially Equivalent |
| K023971 | VACUETTE TRACE ELEMENTS TUBES | Jan 27, 2003 | Substantially Equivalent |
| K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | Jun 28, 2001 | Substantially Equivalent |