FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VEEDA 100% COTTON MENSTRUAL TAMPON
K Number: K130609
·
Decision Mar 21, 2013
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
1
Review Days
14
Basic Information
- Device Name
- VEEDA 100% COTTON MENSTRUAL TAMPON
- K Number
- K130609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Naturalena Brands, Inc.
- Date Received
- March 7, 2013
- Decision Date
- March 21, 2013
- Product Code
- HEB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
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