SECURE


Device Classification Name

cement, dental

510(k) Number K073698
Device Name SECURE
Applicant
PARKELL, INC.
300 executive dr.
edgewood, 
NY 
11717

Applicant Contact daniel r schechter
Correspondent
PARKELL, INC.
300 executive dr.
edgewood, 
NY 
11717

Correspodent Contact daniel r schechter
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 12/31/2007
Decision Date 03/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No