Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Intravenous Catheter Force-Activated Separation Device.
510(k) Number K230266
Device Name Orchid Safety Release Valve
Applicant
Linear Health Sciences, LLC
5333 Wisteria Dr.
Oklahoma City,  OK  73142
Applicant Contact Daniel Clark
Correspondent
Medtactics, LLC
19924 NE 19th Pl.
Miami,  FL  33179
Correspondent Contact Jessica Czamanski
Regulation Number880.5220
Classification Product Code
QOI  
Date Received01/31/2023
Decision Date 05/04/2023
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
-
-