FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMTEX 100% COTTON TAMPONS
K Number: K971228
·
Decision Apr 9, 1997
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- FEMTEX 100% COTTON TAMPONS
- K Number
- K971228
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Regu-Tech Assoc., Inc.
- Date Received
- January 21, 1997
- Decision Date
- April 9, 1997
- Product Code
- HEB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
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