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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 K211097
Device Name Banyan USA Surgical Mask Level 3
Applicant
Banyan USA LLC
390 Oser Avenue
Hauppauge,  NY  11788
Applicant Contact Ricardo Ryan
Correspondent
MDI Consultants Inc.
55 Northern Blvd, Suite 200
Great Neck,  NY  11021
Correspondent Contact Timothy Kania
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/13/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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