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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K781099
Device Name SURGICAL GOWNS AND DRAPES
Applicant
Convertors
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Convertors
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/03/1978
Decision Date 08/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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