FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD UTERINE MANIPULATOR
K Number: K904079
·
Decision Feb 7, 1991
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
645
Review Days
155
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Basic Information
- Device Name
- BARD UTERINE MANIPULATOR
- K Number
- K904079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- September 5, 1990
- Decision Date
- February 7, 1991
- Product Code
- LKF
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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