FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAXI & MINI SHIELDS
K Number: K820960
·
Decision May 14, 1982
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
4
Review Days
38
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Basic Information
- Device Name
- MAXI & MINI SHIELDS
- K Number
- K820960
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Dafoe & Dafoe, Inc.
- Date Received
- April 6, 1982
- Decision Date
- May 14, 1982
- 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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