FDA 510(k) Premarket Notification K792141: CONTINUOUS FLUSH DEVICE

Submission Details & Decision

Normalized public record details for 510(k) notification K792141.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K792141

Applicant / Sponsor

Pharmaseal Div., Baxter Healthcare Corp.

Device Name

CONTINUOUS FLUSH DEVICE

Product Code

KRA

Decision Date

1979-12-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1979-10-22

Related Establishments / Registrations

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