FDA 510(k) Application Details - K963434

Device Classification Name	Pump, Infusion, Ophthalmic   More FDA Info for this Device
510(K) Number	K963434
Device Name	Pump, Infusion, Ophthalmic
Applicant	ESCALON TREK MEDICAL 822 SWAN DR. MUKWONAGO, WI 53149 US Other 510(k) Applications for this Company
Contact	RONALD L HUENEKE Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/1996
Decision Date	11/25/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review