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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 K790882
Device Name LEAD INTRODUCER SET
Applicant
Introstat
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Introstat
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/08/1979
Decision Date 06/11/1979
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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