STERILS SINGLE-USE I/A HANDPIECES


Device Classification Name

unit, phacofragmentation

510(k) Number K073023
Device Name STERILS SINGLE-USE I/A HANDPIECES
Applicant
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

Applicant Contact ned luce
Correspondent
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

Correspodent Contact ned luce
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 10/26/2007
Decision Date 03/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No