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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
Predetermined Change
Control Plan Authorized		 No
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