CLS-2000 UNIT


Device Classification Name

sterilizer, steam

510(k) Number K024133
Device Name CLS-2000 UNIT
Original Applicant
DENTSPLY INTL.
570 west college ave.
york, 
PA 
17405 -0872

Original Contact p. jeffery lehn
Regulation Number 880.6880
Classification Product Code
FLE  
Date Received 12/16/2002
Decision Date 10/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No