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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 K945045
Device Name PATIENT EXAINATION GLOVES
Applicant
Phoenix Medical Technology, Inc.
U.S. Highway 521 W.
P.O. Box 346
Andrews,  SC  29510
Applicant Contact GROVER C MIXON
Correspondent
Phoenix Medical Technology, Inc.
U.S. Highway 521 W.
P.O. Box 346
Andrews,  SC  29510
Correspondent Contact GROVER C MIXON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/14/1994
Decision Date 01/02/1995
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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