FDA 510(k) Premarket Notification K822361: DIANEAL SOLUTION EXCHANGE DEVICE #5C4193

Submission Details & Decision

Normalized public record details for 510(k) notification K822361.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K822361

Applicant / Sponsor

Travenol Laboratories, S.A.

Device Name

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193

Product Code

FKX

Decision Date

1982-08-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

1982-08-06

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