DISPOSABLE M2-PE MICROKERATOME BLADES


Device Classification Name

keratome, ac-powered

510(k) Number K030401
Device Name DISPOSABLE M2-PE MICROKERATOME BLADES
Applicant
OASIS MEDICAL, INC.
512 s. vermont ave.
glendora, 
CA 
91741 -6205

Applicant Contact yvonne fernandez
Correspondent
OASIS MEDICAL, INC.
512 s. vermont ave.
glendora, 
CA 
91741 -6205

Correspodent Contact yvonne fernandez
Regulation Number 886.4370
Classification Product Code
HNO  
Date Received 02/06/2003
Decision Date 06/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No