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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cranial
510(k) Number K241957
Device Name Talee, Talee PostOp
Applicant
Invent Medical Usa, LLC
1800 Mearns Rd., Suite Y
Warminster,  PA  18974
Applicant Contact Jiri Rosicky
Correspondent
Invent Medical Usa, LLC
1800 Mearns Rd., Suite Y
Warminster,  PA  18974
Correspondent Contact Jiri Rosicky
Regulation Number882.5970
Classification Product Code
MVA  
Subsequent Product Code
OAN  
Date Received07/03/2024
Decision Date 08/30/2024
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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