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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 K905031
Device Name PATIENT EXAMINATION GLOVES
Applicant
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Applicant Contact SAUVE
Correspondent
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Correspondent Contact SAUVE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/07/1990
Decision Date 01/18/1991
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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