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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K892768
Device Name PATIENT EXAMINATION GLOVES (POLY)
Applicant
Promedica Products, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Applicant Contact LEE HAND
Correspondent
Promedica Products, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Correspondent Contact LEE HAND
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/11/1989
Decision Date 06/14/1989
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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