ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET
FDA 510(k) clearance K874293 · decided 1987-12-29
Clearance details
- K-number
- K874293
- Device name
- ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET
- Applicant
- Ackrad Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-10-20
- Decision date
- 1987-12-29
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cranford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.