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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular, General & Plastic Surgery
510(k) Number K912645
Device Name ATRIUMS PDR THORACIC CATHETER
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 Number878.4200
Classification Product Code
GBS  
Date Received06/17/1991
Decision Date 09/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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