FDA 510(k) Premarket Notification K770360: HEARING AID, MAICO DM MARK 180

Submission Details & Decision

Normalized public record details for 510(k) notification K770360.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K770360

Applicant / Sponsor

Maico Hearing Instruments, Inc.

Device Name

HEARING AID, MAICO DM MARK 180

Product Code

ESD

Decision Date

1977-02-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

1977-02-22

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