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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 K152197
Device Name Skypro, SP01 Mask
Applicant
Skypro Medical Supplies Company
C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat
1-33 Cheung Tat Road, Tsing Yi, NT
Hong Kong,  CN
Applicant Contact Cyrus Wong
Correspondent
Skypro Medical Supplies Company
C301, Tsing Yi Industrial Centre Phase 2,
1-33 Cheung Tat Road, Tsing Yi, NT
Hong Kong,  CN
Correspondent Contact Cyrus Wong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/05/2015
Decision Date 08/26/2016
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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