URETERAL CATHETER AND ACCESSORIES
FDA 510(k) clearance K934419 · decided 1994-05-25
Clearance details
- K-number
- K934419
- Device name
- URETERAL CATHETER AND ACCESSORIES
- Applicant
- Urological Associates of Central Jersey P.A.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-13
- Decision date
- 1994-05-25
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- EYK
- Device class
- 1
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- South Plainfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.