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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic, Porous Polyethylene
510(k) Number K171037
Device Name PoreStar Patient Specific Implant
Applicant
Anatomics Pty, Ltd.
23-27 Wellington St.
St Kilda,  AU 3182
Applicant Contact Joanne Flatley
Correspondent
Brandwood Biomedical
Level 8, 1 Chandos St.
St Leonards,  AU 2065
Correspondent Contact Nicholas Connell
Regulation Number874.3620
Classification Product Code
JOF  
Subsequent Product Code
GWO  
Date Received04/06/2017
Decision Date 12/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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