GAYHEART CORNEAL EXCISION DEVICE


Device Classification Name

trephine, manual, ophthalmic

510(k) Number K022843
Device Name GAYHEART CORNEAL EXCISION DEVICE
Original Applicant
STEPHENS INSTRUMENTS
2500 sandersville rd.
lexington, 
KY 
40511

Original Contact archana johnson
Regulation Number 886.4350
Classification Product Code
HRH  
Date Received 08/27/2002
Decision Date 11/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No