FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UTERINE INJECTOR 4.0MM
K Number: K841682
·
Decision Jul 3, 1984
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
12
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- UTERINE INJECTOR 4.0MM
- K Number
- K841682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Humi Corp.
- Date Received
- April 23, 1984
- Decision Date
- July 3, 1984
- Product Code
- HES
- 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 |
|---|---|---|---|
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Humi Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K841681 | UTERINE MANIPULATOR 4.5MM | Apr 23, 1984 | Unknown |