FDA 510(k) Application Details - K980399

Device Classification Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered   More FDA Info for this Device
510(K) Number	K980399
Device Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant	PEREGRINE SURGICAL LTD. 4050D SKYRON DR. DOYLESTOWN, PA 18901 US Other 510(k) Applications for this Company
Contact	TODD RICHMOND Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	HQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/1998
Decision Date	04/30/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review