NPseal (20 and 25)— 510(k) K241522

Substantially Equivalent

Guard Medical, Inc.

FDA 510(k) clearance K241522 for NPseal (20 and 25), Substantially Equivalent on 2024-08-15. Applicant: Guard Medical, Inc..

Clearance details

Applicant: Guard Medical, Inc.
Product code: Code OKO
Advisory panel: General, Plastic Surgery
Date received: 2024-05-29
Decision date: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

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