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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K982299
Device Name SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
Applicant
Daig Corp.
14901 Deveau Place
Minnetonka,  MN  55345 -2126
Applicant Contact MICHAEL G SCHULTZ
Correspondent
Daig Corp.
14901 Deveau Place
Minnetonka,  MN  55345 -2126
Correspondent Contact MICHAEL G SCHULTZ
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/01/1998
Decision Date 10/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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