Dental Barrier and Sleeves— 510(k) K250735

Substantially Equivalent

Fomed Industries, Inc.

FDA 510(k) clearance K250735 for Dental Barrier and Sleeves, Substantially Equivalent on 2025-06-10. Applicant: Fomed Industries, Inc..

Clearance details

Applicant: Fomed Industries, Inc.
Product code: Code PEM
Advisory panel: General, Plastic Surgery
Date received: 2025-03-11
Decision date: 2025-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qian Jing City, CN

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