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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K072248
Device Name VIAPEEL PEELABLE INTRODUCER
Applicant
Enpath Medical, Inc.
2300 Berkshire Lane N.
Pymouth,  MN  55441
Applicant Contact PATRICE STROMBERG
Correspondent
Enpath Medical, Inc.
2300 Berkshire Lane N.
Pymouth,  MN  55441
Correspondent Contact PATRICE STROMBERG
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/13/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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