FDA 510(k) Application Details - K200532

Device Classification Name	Polymer, Ent Synthetic, Porous Polyethylene   More FDA Info for this Device
510(K) Number	K200532
Device Name	Polymer, Ent Synthetic, Porous Polyethylene
Applicant	Anatomics Pty, Ltd. Warehouse 1, 246 East Boundary Road Bentleigh East 3165 AU Other 510(k) Applications for this Company
Contact	Christine Scifert Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	JOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2020
Decision Date	06/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review