FDA 510(k) Premarket Notification K900478: WOODLYN FULL APERTURE TRIAL LENS SET

Submission Details & Decision

Normalized public record details for 510(k) notification K900478.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K900478

Applicant / Sponsor

Woodlyn, Inc.

Device Name

WOODLYN FULL APERTURE TRIAL LENS SET

Product Code

HPC

Decision Date

1990-02-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Traditional

Third Party Flag

Date Received

1990-02-01

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