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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 K892079
Device Name CHAMP-PAQ VINYL PATIENT EXAM GLOVES
Applicant
Winmed Instruments Mfg. Corp.
9th Floor, # 83-85, Chung-Hsiao
East Rd., Sec. 6, Taipei
11504, Taiwan R.O.C.,  TW
Applicant Contact BENSON H TING
Correspondent
Winmed Instruments Mfg. Corp.
9th Floor, # 83-85, Chung-Hsiao
East Rd., Sec. 6, Taipei
11504, Taiwan R.O.C.,  TW
Correspondent Contact BENSON H TING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/03/1989
Decision Date 09/01/1989
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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