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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 K892246
Device Name CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES
Applicant
B Und J Instrument, Inc.
760 Stimson Ave.
City Of Industry,  CA  91745
Applicant Contact ADEN H TING
Correspondent
B Und J Instrument, Inc.
760 Stimson Ave.
City Of Industry,  CA  91745
Correspondent Contact ADEN H TING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/05/1989
Decision Date 08/21/1989
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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