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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K894718
Device Name ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
Applicant
INTERMEDICS, INC.
P.O. BOX 617
FREEPORT,  TX  77541 -0617
Applicant Contact JAMES S MILLER
Correspondent
INTERMEDICS, INC.
P.O. BOX 617
FREEPORT,  TX  77541 -0617
Correspondent Contact JAMES S MILLER
Regulation Number870.3620
Classification Product Code
DTD  
Date Received07/25/1989
Decision Date 09/05/1989
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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