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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 K900933
Device Name PROTEX LATEX EXAMINATION GLOVES
Applicant
Seyen Intl., Inc.
2530 Corporate Pl.
#A-111
Monterey Park,  CA  91754
Applicant Contact MIKE CHANG
Correspondent
Seyen Intl., Inc.
2530 Corporate Pl.
#A-111
Monterey Park,  CA  91754
Correspondent Contact MIKE CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/28/1990
Decision Date 03/27/1990
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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