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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respirator, surgical
510(k) Number K063334
Device Name SHANGHAI GANGHAI MODEL GIKO 1400
Applicant
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD.
7380 36TH COURT
VERO BEACH,  FL  32967
Applicant Contact JOSEPH Z ZDROK
Correspondent
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD.
7380 36TH COURT
VERO BEACH,  FL  32967
Correspondent Contact JOSEPH Z ZDROK
Regulation Number878.4040
Classification Product Code
MSH  
Date Received11/06/2006
Decision Date 12/08/2006
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
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