CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER


Device Classification Name

unit, cryophthalmic, ac-powered

510(k) Number K112093
Device Name CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Applicant
KEELER INSTRUMENTS, INC.
456 pkwy.
broomall, 
PA 
19008

Applicant Contact eugene r vanarsdale
Correspondent
KEELER INSTRUMENTS, INC.
456 pkwy.
broomall, 
PA 
19008

Correspodent Contact eugene r vanarsdale
Regulation Number 886.4170
Classification Product Code
HRN  
Date Received 07/22/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Special
Reviewed by Third Party No

Combination Product

No