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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 K203101
Device Name Secure Wear USA Surgical Face Mask
Applicant
Secured Ortho Manufacturing of America, LLC
28 W. Jefryn Blvd. Suite C
Deer Park,  NY  11729
Applicant Contact Vincent Benenati
Correspondent
Secured Ortho Manufacturing of America, LLC
28 W. Jefryn Blvd. Suite C
Deer Park,  NY  11729
Correspondent Contact Vincent Benenati
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/14/2020
Decision Date 03/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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