FDA 510(k) Application Details - K132614

Device Classification Name	Photocoagulator And Accessories   More FDA Info for this Device
510(K) Number	K132614
Device Name	Photocoagulator And Accessories
Applicant	PEREGRINE SURGICAL, LTD. 51 Britain Drive Doylestown, PA 18901 US Other 510(k) Applications for this Company
Contact	RYAN O'LEARY Other 510(k) Applications for this Contact
Regulation Number	886.4690   More FDA Info for this Regulation Number
Classification Product Code	HQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2013
Decision Date	11/14/2013
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