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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K904928
Device Name PALAVIT GLC
Applicant
Kulzer, Inc.
10005 Muirlands Blvd.
Unit G.
Irvine,  CA  92718
Applicant Contact SHARON PARKER
Correspondent
Kulzer, Inc.
10005 Muirlands Blvd.
Unit G.
Irvine,  CA  92718
Correspondent Contact SHARON PARKER
Regulation Number872.6890
Classification Product Code
EGD  
Date Received10/31/1990
Decision Date 06/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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