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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 K093179
Device Name MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
Applicant
H&H Research Company
1245 Wilshire Blvd. #501
Los Angeles,  CA  90017
Applicant Contact JONG HUANG
Correspondent
H&H Research Company
1245 Wilshire Blvd. #501
Los Angeles,  CA  90017
Correspondent Contact JONG HUANG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/08/2009
Decision Date 07/14/2010
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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