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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K843200
Device Name SITE STRIP
Applicant
E-Med Corp.
Graydon, Head & Ritchey
P.O. Box 6464
Cincinnati,  OH  45201
Applicant Contact THOMAS W KAHLE
Correspondent
E-Med Corp.
Graydon, Head & Ritchey
P.O. Box 6464
Cincinnati,  OH  45201
Correspondent Contact THOMAS W KAHLE
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/14/1984
Decision Date 03/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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