REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601

Pulse-generator, Pacemaker, External

REMINGTON MEDICAL, INC.

The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Disposable Extension Cable Fas-loc Fl-601.

Pre-market Notification Details

Device IDK940467
510k NumberK940467
Device Name:REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
ClassificationPulse-generator, Pacemaker, External
Applicant REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta,  GA  30350
ContactFredrick L Aycock
CorrespondentFredrick L Aycock
REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta,  GA  30350
Product CodeDTE  
CFR Regulation Number870.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-02
Decision Date1994-11-01

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