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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 K870041
Device Name FLEXIBLE FASCICULATED BONE PLATE
Applicant
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Applicant Contact WILLIAM X HALLORAN
Correspondent
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Correspondent Contact WILLIAM X HALLORAN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/05/1987
Decision Date 07/17/1987
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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