THERMIQUE


Device Classification Name

tester, pulp

510(k) Number K022097
Device Name THERMIQUE
Original Applicant
PARKELL, INC.
155 schmitt blvd.
p.o. box 376
farmingdale, 
NY 
11735

Original Contact daniel r schechter
Regulation Number 872.1720
Classification Product Code
EAT  
Date Received 06/27/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No