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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K915591
Device Name STERILE GAUZE PADS
Applicant
Eagle Medical, Inc.
160 Corporate Woods Court
P.O. Box 640
Bridgeton,  MO  63044
Applicant Contact ARNOLD LERMAN
Correspondent
Eagle Medical, Inc.
160 Corporate Woods Court
P.O. Box 640
Bridgeton,  MO  63044
Correspondent Contact ARNOLD LERMAN
Regulation Number878.4014
Classification Product Code
NAB  
Date Received12/13/1991
Decision Date 01/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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