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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Band, Elastic, Orthodontic
510(k) Number K931462
Device Name GLENROE CHAIN
Applicant
Glenroe Technologies, Inc.
1912 44th Ave. E
Bradenton,  FL  34203
Applicant Contact JOHN BOZMAN
Correspondent
Glenroe Technologies, Inc.
1912 44th Ave. E
Bradenton,  FL  34203
Correspondent Contact JOHN BOZMAN
Regulation Number872.5410
Classification Product Code
ECI  
Date Received03/24/1993
Decision Date 07/22/1993
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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