FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNSCENTED MENSTRUAL PAD TIER-1 REVIEW
K Number: K940377
·
Decision Mar 25, 1994
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
2
Review Days
58
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Basic Information
- Device Name
- UNSCENTED MENSTRUAL PAD TIER-1 REVIEW
- K Number
- K940377
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Eldari, Ltd.
- Date Received
- January 26, 1994
- Decision Date
- March 25, 1994
- Product Code
- HHD
- 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 |
|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | FDA class 1 | Obstetrics/Gynecology |
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Other Clearances by Eldari, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K934662 | UNSCENTED MENSTRUAL PAD | Feb 24, 1994 | Substantially Equivalent |