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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord, retraction
510(k) Number K131799
FOIA Releasable 510(k) K131799
Device Name QUICKNIT
Applicant
MICROCOPY, DIV. OF NEO-FLO INC.
3120 MOON STATION RD. NW
KENNESAW,  GA  30144 -9017
Applicant Contact PEGGY GOBER
Correspondent
MICROCOPY, DIV. OF NEO-FLO INC.
3120 MOON STATION RD. NW
KENNESAW,  GA  30144 -9017
Correspondent Contact PEGGY GOBER
Classification Product Code
MVL  
Date Received06/19/2013
Decision Date 01/16/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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