STELLA BIO— 510(k) K210002

Substantially Equivalent

Egzotech Sp. Z O. O.

FDA 510(k) clearance K210002 for STELLA BIO, Substantially Equivalent on 2021-10-01. Applicant: Egzotech Sp. Z O. O..

Clearance details

Applicant: Egzotech Sp. Z O. O.
Product code: Code IPF
Advisory panel: Physical Medicine
Date received: 2021-01-04
Decision date: 2021-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gliwice, PL

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