FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOBRUSH(TM) DEVICE; OMNIBRUSH
K Number: K897070
·
Decision Sep 10, 1990
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
8
Applicant Total
4
Review Days
262
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Basic Information
- Device Name
- ENDOBRUSH(TM) DEVICE; OMNIBRUSH
- K Number
- K897070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Cytobrush, Inc.
- Date Received
- December 22, 1989
- Decision Date
- September 10, 1990
- Product Code
- HFE
- 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 |
|---|---|---|---|
| HFE | Brush, Endometrial | FDA class 2 | Obstetrics/Gynecology |
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