STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101


Device Classification Name

sterilizer, steam

510(k) Number K072466
Device Name STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
Applicant
SCICAN LTD.
1440 don mills rd.
toronto, ontario, 

CA

m3b 3p9

Applicant Contact teresa boyce
Correspondent
SCICAN LTD.
1440 don mills rd.
toronto, ontario, 

CA

m3b 3p9

Correspodent Contact teresa boyce
Regulation Number 880.6880
Classification Product Code
FLE  
Date Received 09/04/2007
Decision Date 12/19/2007
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