PRIZM KERATOME BLADE, MODEL MK8512M2

Device Classification Name

keratome, ac-powered

510(k) Number K033236
Device Name PRIZM KERATOME BLADE, MODEL MK8512M2
Applicant
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 bentley circle
tustin, 
CA 
92680

Applicant Contact don haar
Correspondent
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 bentley circle
tustin, 
CA 
92680

Correspodent Contact don haar
Regulation Number 886.4370
Classification Product Code
HNO  
Date Received 10/06/2003
Decision Date 03/26/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No