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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Remover, Crown
510(k) Number K833289
Device Name C & B 61 PENTRON C & B61
Applicant
Genesis Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Genesis Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EIS  
Date Received09/22/1983
Decision Date 12/29/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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