Atlas FDA

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.