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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K925890
Device Name MIRROR, MOUTH
Applicant
Protector, Inc.
C/O Asian Pacific Imports
P.O. Box 92195
Long Beach,  CA  90809
Applicant Contact MICHAEL W GUENTHER
Correspondent
Protector, Inc.
C/O Asian Pacific Imports
P.O. Box 92195
Long Beach,  CA  90809
Correspondent Contact MICHAEL W GUENTHER
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received11/16/1992
Decision Date 02/15/1994
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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