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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 K200532
Device Name StarPore
Applicant
Anatomics Pty, Ltd.
Warehouse 1, 246 E. Boundary Rd.
Bentleigh East,  AU 3165
Applicant Contact Christine Scifert
Correspondent
Anatomics Pty, Ltd.
Warehouse 1, 246 E. Boundary Rd.
Bentleigh East,  AU 3165
Correspondent Contact Christine Scifert
Regulation Number874.3620
Classification Product Code
JOF  
Subsequent Product Code
GWO  
Date Received03/02/2020
Decision Date 06/02/2020
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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