BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME


Device Classification Name

keratome, battery-powered

510(k) Number K022637
Device Name BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
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 08/08/2002
Decision Date 10/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls