BD K-4000 MICROKERATOME SYSTEM


Device Classification Name

keratome, battery-powered

510(k) Number K023092
Device Name BD K-4000 MICROKERATOME SYSTEM
Original Applicant
BECTON DICKINSON & CO.
1 becton dr.
franklin lakes, 
NJ 
07417 -1885

Original Contact eileen t schweighardt
Regulation Number 886.4370
Classification Product Code
HMY  
Date Received 09/18/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls