FDA 510(k) Application Details - K171037

Device Classification Name	Polymer, Ent Synthetic, Porous Polyethylene   More FDA Info for this Device
510(K) Number	K171037
Device Name	Polymer, Ent Synthetic, Porous Polyethylene
Applicant	Anatomics Pty Ltd 23-27 Wellington St St Kilda 3182 AU Other 510(k) Applications for this Company
Contact	Joanne Flatley 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	04/06/2017
Decision Date	12/27/2017
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