FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
O'REGAN DISPOSABLE ANOSCOPE
K Number: K020702
·
Decision Mar 29, 2002
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
25
Applicant Total
1
Review Days
25
Basic Information
- Device Name
- O'REGAN DISPOSABLE ANOSCOPE
- K Number
- K020702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CANADIAN THEATRE PRODUCTS LTD.
- Date Received
- March 4, 2002
- Decision Date
- March 29, 2002
- Product Code
- FER
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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