ACEM


Device Classification Name

cord, electric, for endoscope

510(k) Number K111013
Device Name ACEM
Applicant
SANDHILL SCIENTIFIC, INC.
4655 kirkwood ct
boulder, 
CO 
80301

Applicant Contact lewis ward
Correspondent
SANDHILL SCIENTIFIC, INC.
4655 kirkwood ct
boulder, 
CO 
80301

Correspodent Contact lewis ward
Regulation Number 876.1500
Classification Product Code
FFZ  
Subsequent Product Codes
JOM   MYE  
Date Received 04/11/2011
Decision Date 12/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No