F 900


Device Classification Name

tonometer, manual

510(k) Number K022054
Device Name F 900
Original Applicant
C.S.O. S.R.L.
197 belvoir rd.
williamsville, 
NY 
14221

Original Contact r. brent miner
Regulation Number 886.1930
Classification Product Code
HKY  
Date Received 06/24/2002
Decision Date 08/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No