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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K932370
Device Name REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET
Applicant
REMINGTON MEDICAL, INC.
8601 dunwoody pl., suite 510
atlanta,  GA  30350
Applicant Contact frederick l.aycock
Correspondent
REMINGTON MEDICAL, INC.
8601 dunwoody pl., suite 510
atlanta,  GA  30350
Correspodent Contact frederick l.aycock
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/14/1993
Decision Date 11/09/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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