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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 K892673
Device Name PATIENT EXAM GLOVES (VINYL) MFG. PRECIOUS MOUNTAIN
Applicant
T.C. Electronics Co.
10605 Bommer Cir. Suite 101
Dallas,  TX  75238
Applicant Contact MIKE CHENG
Correspondent
T.C. Electronics Co.
10605 Bommer Cir. Suite 101
Dallas,  TX  75238
Correspondent Contact MIKE CHENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/11/1989
Decision Date 05/31/1989
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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