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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K234081
Device Name RedDrop ONE (One)
Applicant
Reddrop DX
2401 Research Blvd. #206
Fort Collins,  CO  80526
Applicant Contact Kris Buchanan
Correspondent
Reddrop DX
2401 Research Blvd. #206
Fort Collins,  CO  80526
Correspondent Contact Kris Buchanan
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/22/2023
Decision Date 03/21/2024
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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