FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMMETT IUD THREAD RETREIVER
K Number: K820115
·
Decision Feb 5, 1982
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
5
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- EMMETT IUD THREAD RETREIVER
- K Number
- K820115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Proto-Med, Inc.
- Date Received
- January 18, 1982
- Decision Date
- February 5, 1982
- Product Code
- HHF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | FDA class 1 | Obstetrics/Gynecology |
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