KOWA GENESIS HAND-HELD FUNDUS CAMERA— 510(k) K954781

Substantially Equivalent

Kowa Optimed, Inc.

FDA 510(k) clearance K954781 for KOWA GENESIS HAND-HELD FUNDUS CAMERA, Substantially Equivalent on 1995-12-01. Applicant: Kowa Optimed, Inc..

Clearance details

Applicant: Kowa Optimed, Inc.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 1995-10-17
Decision date: 1995-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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