FDA 510(k) Application Details - K002932

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K002932
Device Name	Unit, Phacofragmentation
Applicant	SYNTEC, INC. 733 MANSION RD. WINFIELD, MO 63389 US Other 510(k) Applications for this Company
Contact	JIM EASLEY 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	09/20/2000
Decision Date	01/04/2001
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