Blue Eye— 510(k) K241591

Substantially Equivalent

The Standard Co., Ltd.

FDA 510(k) clearance K241591 for Blue Eye, Substantially Equivalent on 2024-07-03. Applicant: The Standard Co., Ltd..

Clearance details

Applicant: The Standard Co., Ltd.
Product code: Code PLL
Advisory panel: Gastroenterology, Urology
Date received: 2024-06-03
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Gunpo-Si, KR

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