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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K190125
Device Name FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
Applicant
T.A.G. Medical Products Corporation, Ltd
Gaaton
gaaton,  IL 2513000
Applicant Contact shlomi dines
Correspondent
T.A.G. Medical Products Corporation, Ltd
Gaaton
gaaton,  IL 2513000
Correspondent Contact anat rozen
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/28/2019
Decision Date 05/19/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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