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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K080144
Device Name MANDREL GUIDEWIRES OR M-WIRES
Applicant
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact DEEP PAL
Correspondent
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact DEEP PAL
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/22/2008
Decision Date 02/26/2008
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
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