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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 K992289
Device Name VINYL POWDERED EXAM GLOVE / CAT.# 15-020
Applicant
Vitalcare Group, Inc.
15800 NW 13th Ave.
Miami,  FL  33169
Applicant Contact GINGER TALLEY
Correspondent
Vitalcare Group, Inc.
15800 NW 13th Ave.
Miami,  FL  33169
Correspondent Contact GINGER TALLEY
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/07/1999
Decision Date 08/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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