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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K853188
Device Name TRANSFER DEVICE
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 Number880.5440
Classification Product Code
LHI  
Date Received07/30/1985
Decision Date 08/21/1985
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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