KENDALL CURITY URETERAL CATHETER
FDA 510(k) clearance K964899 · decided 1997-02-07
Clearance details
- K-number
- K964899
- Device name
- KENDALL CURITY URETERAL CATHETER
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Decision
- Substantially Equivalent
- Date received
- 1996-12-03
- Decision date
- 1997-02-07
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- EYB
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.