FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEMININE HYGIENE DEVICE
K Number: K831667
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
11
Applicant Total
1
Review Days
112
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Basic Information
- Device Name
- FEMININE HYGIENE DEVICE
- K Number
- K831667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Snow Willow Co.
- Date Received
- May 23, 1983
- Decision Date
- September 12, 1983
- Product Code
- HED
- 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 |
|---|---|---|---|
| HED | Douche Apparatus, Vaginal, Therapeutic | FDA class 1 | Obstetrics/Gynecology |
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