NCI SPATULA


Device Classification Name

graft insertion instrument for endothelial keratoplasty

510(k) Number K110734
Device Name NCI SPATULA
Applicant
FISCHER SURGICAL INC.
1012 palmer lane,
suite 200
imperial, 
MO 
63052

Applicant Contact jessica dixon
Correspondent
FISCHER SURGICAL INC.
1012 palmer lane,
suite 200
imperial, 
MO 
63052

Correspodent Contact jessica dixon
Regulation Number 886.4300
Classification Product Code
OTZ  
Date Received 03/16/2011
Decision Date 05/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No