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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K924351
Device Name GLENROE ELASTIBITE STIMULATOR
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 Number872.5525
Classification Product Code
KMY  
Date Received08/28/1992
Decision Date 01/06/1994
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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