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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K861176
Device Name MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Applicant Contact KEN BISHOP
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Correspondent Contact KEN BISHOP
Regulation Number870.3680
Classification Product Code
DTB  
Date Received03/31/1986
Decision Date 04/29/1986
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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