A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5


the company

Device Classification Name

unit, phacofragmentation

510(k) Number K002986
Device Name A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
Original Applicant
A.R.C. LASER AG
2417 south 3850 west
salt lake city, 
UT 
84120

Original Contact daniel hoefer
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 09/25/2000
Decision Date 11/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No