FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WHENEVER UNSCENTED REGULAR THIN MAXI-PADS
K Number: K861355
·
Decision Apr 23, 1986
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
4
Review Days
13
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Basic Information
- Device Name
- WHENEVER UNSCENTED REGULAR THIN MAXI-PADS
- K Number
- K861355
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Marcal Paper Mills, Inc.
- Date Received
- April 10, 1986
- Decision Date
- April 23, 1986
- 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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