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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 K802076
Device Name STIFF STYLETS
Applicant
Cardiac Pacemakers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cardiac Pacemakers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1380
Classification Product Code
DRB  
Date Received08/28/1980
Decision Date 09/26/1980
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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