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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 K892976
Device Name SINGLE USE VINYL EXAM GLOVES - COLOR CODED
Applicant
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Applicant Contact J. F SAUVE'
Correspondent
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Correspondent Contact J. F SAUVE'
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/12/1989
Decision Date 06/22/1989
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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