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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K173844
Device Name Titan Ag 200
Applicant
Specialty Fibres and Materials, Ltd.
101 Lockhurst Ln.
Coventry,  GB Cv6 5sf
Applicant Contact Lindie Marx
Correspondent
Specialty Fibres and Materials, Ltd.
101 Lockhurst Ln.
Coventry,  GB Cv6 5sf
Correspondent Contact Lindie Turvey
Classification Product Code
FRO  
Date Received12/19/2017
Decision Date 08/09/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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