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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name N95 Respirator With Antimicrobial/Antiviral Agent
510(k) Number K150729
Device Name SpectraShield 9500 Surgical N95 Respirator
Applicant
Nexera Medical, Inc.
3343 W. Commercial Blvd., Suite 103
Ft.Lauderdale,  FL  33309
Applicant Contact Paul Sallarulo
Correspondent
Nexera Medical, Inc.
3343 W. Commercial Blvd., Suite 103
Ft.Lauderdale,  FL  33309
Correspondent Contact Paul Sallarulo
Regulation Number878.4040
Classification Product Code
ONT  
Date Received03/20/2015
Decision Date 12/29/2015
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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