FDA 510(k) Application Details - K022833

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K022833
Device Name	Unit, Phacofragmentation
Applicant	BENJAMIN BIOMEDICAL, INC. 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ARTHUR WARD 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	08/26/2002
Decision Date	09/09/2002
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	Y
Expedited Review