FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SULLIVAN VARIABLE STIFFNESS CABLE
K Number: K901610
·
Decision Jun 29, 1990
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
108
Applicant Total
91
Review Days
84
Basic Information
- Device Name
- SULLIVAN VARIABLE STIFFNESS CABLE
- K Number
- K901610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- WILSON-COOK MEDICAL, INC.
- Date Received
- April 6, 1990
- Decision Date
- June 29, 1990
- Product Code
- FDF
- 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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