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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 K860023
Device Name COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
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 Received01/03/1986
Decision Date 01/10/1986
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
Recalls CDRH Recalls
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