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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Latex Patient Examination Glove
510(k) Number K895490
Device Name YUETONG LATEX EXAMINATION GLOVES
Applicant
The New York Whitney Group
311 E. 38th St.
New York,  NY  10016
Applicant Contact LI, M.D.
Correspondent
The New York Whitney Group
311 E. 38th St.
New York,  NY  10016
Correspondent Contact LI, M.D.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/29/1989
Decision Date 01/17/1990
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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