DSG RELAXER SPLINT


Device Classification Name

mouthguard, prescription

510(k) Number K022627
Device Name DSG RELAXER SPLINT
Original Applicant
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP
1801 k st. nw
suite 1200
washington, 
DC 
20006

Original Contact g. brent connor
Classification Product Code
MQC  
Date Received 08/07/2002
Decision Date 03/18/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No