FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERVEX-BRUSH
K Number: K930955
·
Decision May 24, 1994
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
2
Review Days
455
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Basic Information
- Device Name
- CERVEX-BRUSH
- K Number
- K930955
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rovers B.V.
- Date Received
- February 23, 1993
- Decision Date
- May 24, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHT), ordered by most recent decision date.
exCellerator Cervical Collection Device
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Kolplast Cervical Sample Collection Kit
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DISPOSABLE CERVICAL BRUSH
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HISTOBRUSH
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PAPCONE
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BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
FDA 510(k)
FDA Class 2
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Other Clearances by Rovers B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K933870 | VIBA-BRUSH | Jan 5, 1995 | Substantially Equivalent |