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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intravenous Catheter Force-Activated Separation Device.
510(k) Number K232094
Device Name Orchid Safety Release ValveTM
Applicant
Linear Health Sciences, LLC
5333 Wisteria Dr.
Oklahoma City,  OK  73142
Applicant Contact Daniel Clark
Correspondent
Linear Health Sciences, LLC
5333 Wisteria Dr.
Oklahoma City,  OK  73142
Correspondent Contact Jessica Czamanski
Regulation Number880.5220
Classification Product Code
QOI  
Date Received07/13/2023
Decision Date 10/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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