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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K800603
Device Name IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
Applicant
Telectronics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Telectronics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received03/17/1980
Decision Date 03/25/1980
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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