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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K982720
Device Name H-RAY
Applicant
Shijiazhuang Hongray Plastic Products Co., Ltd.
# 135 Xin-Hua W. Rd.
Shijiazhuang,  CN 050081
Applicant Contact LIN CHIN YU
Correspondent
Shijiazhuang Hongray Plastic Products Co., Ltd.
# 135 Xin-Hua W. Rd.
Shijiazhuang,  CN 050081
Correspondent Contact LIN CHIN YU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/04/1998
Decision Date 11/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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