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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 K945535
Device Name GLENROE ORTHO-SIL
Applicant
Glenroe Technologies
1912 44th Ave. E
Bradenton,  FL  34203
Applicant Contact JOHN F BOZMAN
Correspondent
Glenroe Technologies
1912 44th Ave. E
Bradenton,  FL  34203
Correspondent Contact JOHN F BOZMAN
Regulation Number872.6890
Classification Product Code
EGD  
Date Received11/14/1994
Decision Date 01/27/1995
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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