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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 K940467
Device Name REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
Applicant
Remington Medical, Inc.
8601 Dunwoody Pl., Suite 510
Atlanta,  GA  30350
Applicant Contact FREDRICK L AYCOCK
Correspondent
Remington Medical, Inc.
8601 Dunwoody Pl., Suite 510
Atlanta,  GA  30350
Correspondent Contact FREDRICK L AYCOCK
Regulation Number870.3600
Classification Product Code
DTE  
Date Received02/02/1994
Decision Date 11/01/1994
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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