EZ SPLINT & EZ SPLINT PM


Device Classification Name

mouthguard, prescription

510(k) Number K022809
Device Name EZ SPLINT & EZ SPLINT PM
Original Applicant
POWER PRODUCTS, INC.-SPLINTEK
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact carolann kotula
Classification Product Code
MQC  
Date Received 08/23/2002
Decision Date 10/17/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No