NIVEOUS LIQUID DAM


Device Classification Name

dam, rubber

510(k) Number K021613
Device Name NIVEOUS LIQUID DAM
Original Applicant
SHOFU DENTAL CORP.
1225 stone dr.
san marcos, 
CA 
92078

Original Contact robert noble
Regulation Number 872.6300
Classification Product Code
EIE  
Date Received 05/16/2002
Decision Date 06/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No