DISPOSABLE N-PE MICROKERATOME BLADES


Device Classification Name

keratome, ac-powered

510(k) Number K022205
Device Name DISPOSABLE N-PE MICROKERATOME BLADES
Original Applicant
OASIS MEDICAL, INC.
514 south vermont ave.
glendora, 
CA 
91741

Original Contact yvonne fernandez
Regulation Number 886.4370
Classification Product Code
HNO  
Date Received 07/05/2002
Decision Date 10/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No