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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 K040916
Device Name VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
Applicant
Vitalcare Group, Inc.
8935 NW 27th St.
Miami,  FL  33172
Applicant Contact MICHAEL MCAVENIA
Correspondent
Vitalcare Group, Inc.
8935 NW 27th St.
Miami,  FL  33172
Correspondent Contact MICHAEL MCAVENIA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/08/2004
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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