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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K851825
Device Name SCANLAN TUNNELER, SHEATH & TIP
Applicant
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Applicant Contact TIMOTHY M SCANLAN
Correspondent
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Correspondent Contact TIMOTHY M SCANLAN
Regulation Number870.4500
Classification Product Code
DWS  
Date Received04/26/1985
Decision Date 07/12/1985
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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