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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 K980927
Device Name LACTOSORB PANELS AND FASTENERS
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact MARY VERSTYNEN
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact MARY VERSTYNEN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received03/11/1998
Decision Date 06/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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