FDA 510(k) Application Details - K182986

Device Classification Name	Keratoprosthesis, Permanent Implant   More FDA Info for this Device
510(K) Number	K182986
Device Name	Keratoprosthesis, Permanent Implant
Applicant	Massachusetts Eye and Ear Infirmary d/b/a Boston Keratoprosthesis 243 Charles Street Boston, MA 02114 US Other 510(k) Applications for this Company
Contact	James Chodosh Other 510(k) Applications for this Contact
Regulation Number	886.3400   More FDA Info for this Regulation Number
Classification Product Code	HQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2018
Decision Date	01/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review