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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K852777
Device Name BAG DECANTER
Applicant
Advance Medical Designs, Inc.
1400 Marietta Pkwy., Su 105
Marietta,  GA  30067
Applicant Contact JOSEPH R COTTONE
Correspondent
Advance Medical Designs, Inc.
1400 Marietta Pkwy., Su 105
Marietta,  GA  30067
Correspondent Contact JOSEPH R COTTONE
Regulation Number880.5025
Classification Product Code
KPE  
Date Received07/01/1985
Decision Date 08/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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