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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
510(k) Number K933391
Device Name ATRIUM'S HYBRID PTFE
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 Number870.3450
Classification Product Code
DYF  
Date Received07/12/1993
Decision Date 12/15/1994
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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