FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UTERINE SOUND, BURNETT DISPOSABLE
K Number: K781766
·
Decision Dec 7, 1978
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
9
Applicant Total
645
Review Days
52
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Basic Information
- Device Name
- UTERINE SOUND, BURNETT DISPOSABLE
- K Number
- K781766
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- October 16, 1978
- Decision Date
- December 7, 1978
- Product Code
- HHM
- 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 |
|---|---|---|---|
| HHM | Sound, Uterine | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHM), ordered by most recent decision date.
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TEFLON UTERINE SOUND
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UTERINE SOUND
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
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