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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 K892971
Device Name LATEX EXAM GLOVES
Applicant
P.C. COMMERCIAL, INC.
5903 FINECREST DR.
RANCHO PALOS VERDES,  CA  90274
Applicant Contact PAK CHEUNG
Correspondent
P.C. COMMERCIAL, INC.
5903 FINECREST DR.
RANCHO PALOS VERDES,  CA  90274
Correspondent Contact PAK CHEUNG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/03/1989
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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