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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, air handling, enclosure
510(k) Number K911132
Device Name MULTIPLE, SURGICAL DRAPE 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 Number878.5070
Classification Product Code
FZI  
Date Received03/14/1991
Decision Date 05/06/1991
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
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