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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K002534
Device Name EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
Applicant
Eupalamus, LLC
3411 Mandeville Canyon Rd.
Brentwood,  CA  90049
Applicant Contact ANNE LAURITZEN
Correspondent
Eupalamus, LLC
3411 Mandeville Canyon Rd.
Brentwood,  CA  90049
Correspondent Contact ANNE LAURITZEN
Regulation Number870.1380
Classification Product Code
DRB  
Date Received08/16/2000
Decision Date 10/18/2000
Decision Substantially Equivalent (SESE)
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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