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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 K891795
Device Name DISPOSABLE LATEX EXAM GLOVES
Applicant
Eagle Medical, Inc.
11310 Palisades Ct.
Kensington,  MD  20895
Applicant Contact JOHN L WOLF
Correspondent
Eagle Medical, Inc.
11310 Palisades Ct.
Kensington,  MD  20895
Correspondent Contact JOHN L WOLF
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/23/1989
Decision Date 04/26/1989
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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