FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR BLACK LIGHT URETERAL STENT SET
K Number: K873557
·
Decision Feb 11, 1988
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
61
Review Days
161
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Basic Information
- Device Name
- MENTOR BLACK LIGHT URETERAL STENT SET
- K Number
- K873557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mentor Corp.
- Date Received
- September 3, 1987
- Decision Date
- February 11, 1988
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
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