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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 K091121
Device Name ORTHOSTAT
Applicant
Orthocon, Inc.
675 Us Hwy. One
North Brunswick,  NJ  08902
Applicant Contact KENNETH A COLLINS
Correspondent
Orthocon, Inc.
675 Us Hwy. One
North Brunswick,  NJ  08902
Correspondent Contact KENNETH A COLLINS
Classification Product Code
MTJ  
Date Received04/17/2009
Decision Date 04/28/2009
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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