Imc Surgical Face Mask

by International Medsurg Connection 510(k)

Active United States

510(k) K100846

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK100846	Date16 Aug 2010Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K100846
FDA Product Code: FXX

Device Class: Class II
Regulation: 21 CFR Part 878.4040
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

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