FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HISTOBRUSH
K Number: K874604
·
Decision Jan 7, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
3
Review Days
59
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Basic Information
- Device Name
- HISTOBRUSH
- K Number
- K874604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Spectrum Co.
- Date Received
- November 9, 1987
- Decision Date
- January 7, 1988
- Product Code
- HHT
- 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 |
|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | FDA class 2 | Obstetrics/Gynecology |
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