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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K897125
Device Name ATRIUM 2000, CHEST DRAIN
Applicant
Atrium Medical Corp.
17 Clinton Dr.
Hollis,  NH  03049
Applicant Contact TED KARWOSKI
Correspondent
Atrium Medical Corp.
17 Clinton Dr.
Hollis,  NH  03049
Correspondent Contact TED KARWOSKI
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received12/26/1989
Decision Date 03/30/1990
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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