COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
FDA 510(k) clearance K024050 · decided 2003-02-27
Clearance details
- K-number
- K024050
- Device name
- COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-09
- Decision date
- 2003-02-27
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LJE
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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