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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K911131
Device Name STERILE SURGICAL GOWN PACK
Applicant
Central Georgia Ancillary Health Systems
4269 Interstate Pkwy.
Macon,  GA  31204
Applicant Contact JACK HERNDON
Correspondent
Central Georgia Ancillary Health Systems
4269 Interstate Pkwy.
Macon,  GA  31204
Correspondent Contact JACK HERNDON
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/14/1991
Decision Date 09/16/1991
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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