Copioumed AAMI 3 Surgical Gown— 510(k) K251860

Substantially Equivalent

Copioumed International, Inc.

FDA 510(k) clearance K251860 for Copioumed AAMI 3 Surgical Gown, Substantially Equivalent on 2026-02-26. Applicant: Copioumed International, Inc.. Device class: 2.

Clearance details

Applicant
Copioumed International, Inc.
Product code
Code FYA
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taipei City, TW
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