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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K913688
Device Name BUD MAXILLOFACIAL IMPLANT SYSTEM
Applicant
Bud Industries, Inc.
P.O. Box 1
2 N. Main St.
Holland,  NY  14080
Applicant Contact ROBERT E DUTHIE
Correspondent
Bud Industries, Inc.
P.O. Box 1
2 N. Main St.
Holland,  NY  14080
Correspondent Contact ROBERT E DUTHIE
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/19/1991
Decision Date 05/05/1992
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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