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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 K893304
Device Name LATEX EXAMINATION GLOVES
Applicant
Lakewood Ent., Ltd.
8th Floor , # 301
Fu Hsing N. Rd.
Taipei, Taiwan,  TW
Applicant Contact MARK LIN
Correspondent
Lakewood Ent., Ltd.
8th Floor , # 301
Fu Hsing N. Rd.
Taipei, Taiwan,  TW
Correspondent Contact MARK LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/18/1989
Decision Date 09/13/1989
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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