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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 K971360
Device Name SYNTEX
Applicant
Shinemound Enterprise, Inc.
34 Linnell Circle
Billerica,  MA  01821
Applicant Contact HUAN-CHUNG LI
Correspondent
Shinemound Enterprise, Inc.
34 Linnell Circle
Billerica,  MA  01821
Correspondent Contact HUAN-CHUNG LI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/11/1997
Decision Date 12/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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