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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K895454
Device Name SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)
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 Number870.1390
Classification Product Code
DRC  
Date Received09/05/1989
Decision Date 11/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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