UNIDIRECTIONAL OCCLUDER— 510(k) K913230

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K913230 for UNIDIRECTIONAL OCCLUDER, Substantially Equivalent on 1991-10-02. Applicant: Welch Allyn, Inc.. Device class: 1.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1991-07-22
Decision date: 1991-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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