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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, autotransfusion
510(k) Number K022348
Device Name ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Applicant Contact PROSIE REY-FESSLER
Correspondent
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Correspondent Contact PROSIE REY-FESSLER
Regulation Number868.5830
Classification Product Code
CAC  
Subsequent Product Code
FJI  
Date Received07/19/2002
Decision Date 08/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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