FDA 510(k) Premarket Notification K912158: CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY

Submission Details & Decision

Normalized public record details for 510(k) notification K912158.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K912158

Applicant / Sponsor

Medical Device Inspection Co., Inc.

Device Name

CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY

Product Code

FOZ

Decision Date

1991-10-23

Decision / Status

Unknown (SESK)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

1991-05-16

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