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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 K946010
Device Name KAO YING
Applicant
Kao Ying Industrial Co., Ltd.
11321 Heeadlands Ct.
Reston,  VA  22091
Applicant Contact MEHUL RANDERY
Correspondent
Kao Ying Industrial Co., Ltd.
11321 Heeadlands Ct.
Reston,  VA  22091
Correspondent Contact MEHUL RANDERY
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/09/1994
Decision Date 03/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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