FDA 510(k) Premarket Notification K940152: CAMERA COVER WITH TEAR TIP

Submission Details & Decision

Normalized public record details for 510(k) notification K940152.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K940152

Applicant / Sponsor

Hydro-Med Products, Inc.

Device Name

CAMERA COVER WITH TEAR TIP

Product Code

FEM

Decision Date

1994-10-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

1994-01-03

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