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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 K982901
Device Name LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
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
LYY  
Date Received08/17/1998
Decision Date 12/21/1998
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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