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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K241027
Device Name Permatage Settable Bone Putty
Applicant
Orthocon, Inc.
700 Fairfield Ave. - Suite 1
Stamford,  CT  06902
Applicant Contact Schrayer Howard
Correspondent
Orthocon, Inc.
700 Fairfield Ave. - Suite 1
Stamford,  CT  06902
Correspondent Contact Howard Schrayer
Regulation Number882.5300
Classification Product Code
GXP  
Date Received04/15/2024
Decision Date 09/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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