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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K860491
Device Name OSTEO-MESH CRANIAL FAIRING
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact THOMAS A SMITH
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact THOMAS A SMITH
Date Received02/10/1986
Decision Date 03/28/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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