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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 K882695
Device Name RUBBER BAND, STERILE
Applicant
Bioseal
350 N. Palm
Brea,  CA  92621
Applicant Contact WILLIAM L RUNION
Correspondent
Bioseal
350 N. Palm
Brea,  CA  92621
Correspondent Contact WILLIAM L RUNION
Regulation Number872.5410
Classification Product Code
ECI  
Date Received06/27/1988
Decision Date 10/13/1988
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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