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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 K965249
Device Name SPYGLASS ANGIOGRAPHIC CATHETER
Applicant
Daig Corp.
14901 Deveau Place
Minnetonka,  MN  55345 -2126
Applicant Contact JOHN C HEINMILLER
Correspondent
Daig Corp.
14901 Deveau Place
Minnetonka,  MN  55345 -2126
Correspondent Contact JOHN C HEINMILLER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/12/1996
Decision Date 02/21/1997
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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