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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K113112
Device Name CLEARWAY RX NB CATHETER
Applicant
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact MEGAN MCCAGH
Correspondent
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact MEGAN MCCAGH
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/20/2011
Decision Date 11/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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