EI DOWNPAK BARRIER SLEEVES


Device Classification Name

gutta-percha

510(k) Number K073369
Device Name EI DOWNPAK BARRIER SLEEVES
Applicant
HU-FRIEDY MFG. CO., INC
3232 n. rockwell street
chicago, 
IL 
60618

Applicant Contact keith dunn
Correspondent
HU-FRIEDY MFG. CO., INC
3232 n. rockwell street
chicago, 
IL 
60618

Correspodent Contact keith dunn
Regulation Number 872.3850
Classification Product Code
EKM  
Date Received 11/30/2007
Decision Date 02/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No