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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K022809
Device Name EZ SPLINT & EZ SPLINT PM
Applicant
Power Products, Inc.-Splintek
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Power Products, Inc.-Splintek
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Classification Product Code
MQC  
Date Received08/23/2002
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
Predetermined Change
Control Plan Authorized		 No
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