HANSATOME EXCELLUS MICROKERATOME


Device Classification Name

keratome, ac-powered

510(k) Number K021640
Device Name HANSATOME EXCELLUS MICROKERATOME
Original Applicant
BAUSCH & LOMB, INC.
3365 tree ct. industrial blvd.
st. louis, 
MO 
63122 -6694

Original Contact dennis pozzo
Regulation Number 886.4370
Classification Product Code
HNO  
Date Received 05/20/2002
Decision Date 06/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No