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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K250243
Device Name ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
Applicant
Flexicare Medical Limited.
Cynon Valley Business Park Mountain Ash.
Rhondda Cynon Taf,  GB CF45 4ER
Applicant Contact Rebecca Funston
Correspondent
Flexicare Medical Limited.
Cynon Valley Business Park Mountain Ash.
Rhondda Cynon Taf,  GB CF45 4ER
Correspondent Contact Rebecca Funston
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSR  
Date Received01/27/2025
Decision Date 05/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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