FDA 510(k) Application Details - K230266

Device Classification Name

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510(K) Number K230266
Device Name Orchid Safety Release Valve
Applicant Linear Health Sciences, LLC
5333 Wisteria Drive
Oklahoma City, OK 73142 US
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Contact Daniel Clark
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Regulation Number

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Classification Product Code QOI
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Date Received 01/31/2023
Decision Date 05/04/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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