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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K863418
Device Name MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
Applicant
INTERMEDICS, INC.
P.O. BOX 617
FREEPORT,  TX  77541 -0617
Applicant Contact KEN BISHOP
Correspondent
INTERMEDICS, INC.
P.O. BOX 617
FREEPORT,  TX  77541 -0617
Correspondent Contact KEN BISHOP
Regulation Number870.3610
Classification Product Code
DXY  
Date Received09/03/1986
Decision Date 09/24/1986
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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