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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 K090414
Device Name SPECTRASHIELD 9500 SURGICAL MASK
Applicant
NEXERA MEDICAL, INC
1556 EAST COMMERCIAL BLVD.
OAKLAND PARK,  FL  33334 -5752
Applicant Contact PAUL SALLARULO
Correspondent
NEXERA MEDICAL, INC
1556 EAST COMMERCIAL BLVD.
OAKLAND PARK,  FL  33334 -5752
Correspondent Contact PAUL SALLARULO
Regulation Number878.4040
Classification Product Code
ONT  
Date Received02/18/2009
Decision Date 02/24/2011
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
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