NPseal— 510(k) K211130

Substantially Equivalent

Guard Medical, Inc.

FDA 510(k) clearance K211130 for NPseal, Substantially Equivalent on 2021-05-14. Applicant: Guard Medical, Inc..

Clearance details

Applicant: Guard Medical, Inc.
Product code: Code OKO
Advisory panel: General, Plastic Surgery
Date received: 2021-04-16
Decision date: 2021-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

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