FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HAYES VAGINAL SHIELD
K Number: K862478
·
Decision Nov 24, 1986
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
10
Applicant Total
4
Review Days
147
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Basic Information
- Device Name
- HAYES VAGINAL SHIELD
- K Number
- K862478
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Franklin Medical USA, Inc.
- Date Received
- June 30, 1986
- Decision Date
- November 24, 1986
- Product Code
- HDF
- 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 |
|---|---|---|---|
| HDF | Speculum, Vaginal, Metal | FDA class 1 | Obstetrics/Gynecology |
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