FDA 510(k) Application Details - K960287

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K960287
Device Name	Unit, Phacofragmentation
Applicant	NIDEK, INC. 47651 WESTINGHOUSE DR. FREMONT, CA 94539 US Other 510(k) Applications for this Company
Contact	KEN KATO Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/1996
Decision Date	11/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review