FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALLERGEAZE R CLEAR
K Number: K103409
·
Decision Mar 15, 2011
Classifications
1
FEI Numbers
364
Registration Numbers
364
Same Product Code
20
Applicant Total
4
Review Days
113
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Basic Information
- Device Name
- ALLERGEAZE R CLEAR
- K Number
- K103409
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Smartpractice
- Date Received
- November 22, 2010
- Decision Date
- March 15, 2011
- Product Code
- KXF
- 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 |
|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | FDA class 1 | General Hospital |
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