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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K900188
Device Name ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
Applicant
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Applicant Contact RONALD D ARKIN
Correspondent
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Correspondent Contact RONALD D ARKIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/16/1990
Decision Date 05/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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