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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K831768
Device Name EXTERNAL PULSE GENERATOR FOR TEMP. STIM
Applicant
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Correspondent
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Regulation Number870.3600
Classification Product Code
DTE  
Date Received06/01/1983
Decision Date 12/16/1983
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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