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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
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