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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K963975
Device Name VERSATEC 310 ELECTRODE
Applicant
Versatec, Inc.
764 Denison Ct.
P.O. Box 7027
Bloomfield Hills,  MI  48302
Applicant Contact WILLIAM W PETERSON
Correspondent
Versatec, Inc.
764 Denison Ct.
P.O. Box 7027
Bloomfield Hills,  MI  48302
Correspondent Contact WILLIAM W PETERSON
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/03/1996
Decision Date 01/07/1997
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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