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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 K962737
Device Name AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
Applicant
SUPERTEX INDUSTRIAL, S.A. DE C.V.
BELLAVISTA NO. 667,
COL. LINDA VISTA
ZAPOPAN, JALISCO,  MX 45160
Applicant Contact JAMES F LOGAN
Correspondent
SUPERTEX INDUSTRIAL, S.A. DE C.V.
BELLAVISTA NO. 667,
COL. LINDA VISTA
ZAPOPAN, JALISCO,  MX 45160
Correspondent Contact JAMES F LOGAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/15/1996
Decision Date 02/07/1997
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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