FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
ORIBRUSH - STANDARD - B002
K Number: K991593
·
Decision Jun 29, 1999
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
2
Review Days
53
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Basic Information
- Device Name
- ORIBRUSH - STANDARD - B002
- K Number
- K991593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Orifice Medical AB
- Date Received
- May 7, 1999
- Decision Date
- June 29, 1999
- 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
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Other Clearances by Orifice Medical AB
| K Number | Device Name | ||
|---|---|---|---|
| K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 | Jun 29, 1999 | Substantially Equivalent |