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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K880303
Device Name POLYCORD II
Applicant
Technetics, Inc.
481 Cypress Ln.
El Cajon,  CA  92020
Applicant Contact THOMAS J OWEN
Correspondent
Technetics, Inc.
481 Cypress Ln.
El Cajon,  CA  92020
Correspondent Contact THOMAS J OWEN
Regulation Number870.2800
Classification Product Code
DSH  
Date Received01/25/1988
Decision Date 12/05/1988
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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