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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 K892778
Device Name VECOM BRAND PATIENT EXAMINATION GLOVES
Applicant
Koolsum Ent., Inc.
11211 N. Freeway
Houston,  TX  77037
Applicant Contact JULIAN LANGHAM
Correspondent
Koolsum Ent., Inc.
11211 N. Freeway
Houston,  TX  77037
Correspondent Contact JULIAN LANGHAM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 08/10/1989
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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