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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K043302
Device Name NOVA-PULSE
Applicant
Nova Ranger, Inc.
16787 Bernardo Center Dr.
# A-1
San Diego,  CA  92128
Applicant Contact CURTIS M EGAN
Correspondent
Nova Ranger, Inc.
16787 Bernardo Center Dr.
# A-1
San Diego,  CA  92128
Correspondent Contact CURTIS M EGAN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/30/2004
Decision Date 01/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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