FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
K Number: K971881
·
Decision Aug 12, 1997
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
23
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
- K Number
- K971881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Comeg Endoscopy
- Date Received
- May 20, 1997
- Decision Date
- August 12, 1997
- Product Code
- FJL
- 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 |
|---|---|---|---|
| FJL | Resectoscope | FDA class 2 | Gastroenterology, Urology |
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