FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVAGUARD, MODEL 3611001
K Number: K082908
·
Decision Apr 24, 2009
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
206
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Basic Information
- Device Name
- NOVAGUARD, MODEL 3611001
- K Number
- K082908
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- West Pharmaceutical Services, Inc.
- Date Received
- September 30, 2008
- Decision Date
- April 24, 2009
- 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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