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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Bone
510(k) Number K063330
Device Name ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
Applicant
Orthocon, Inc.
167 Stone Hill Rd.
Colts Neck,  NJ  07722
Applicant Contact HOWARD L SCHRAYER
Correspondent
Orthocon, Inc.
167 Stone Hill Rd.
Colts Neck,  NJ  07722
Correspondent Contact HOWARD L SCHRAYER
Classification Product Code
MTJ  
Date Received11/03/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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