DISSCAP
FDA 510(k) clearance K781142 · decided 1978-09-14
Clearance details
- K-number
- K781142
- Device name
- DISSCAP
- Applicant
- Hospal Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-10
- Decision date
- 1978-09-14
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- FJI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.