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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K203064
Device Name ICU Health Surgical Mask
Applicant
Plastikon Industries
688 Sandoval Way
Hayward,  CA  94545
Applicant Contact Paul Gutwald
Correspondent
Hantel Technologies, Inc.
3496 Breakwater Ct.
Hayward,  CA  94545
Correspondent Contact Mary Pascual Gallup
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/09/2020
Decision Date 03/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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