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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrogel Spacer
510(k) Number K220641
Device Name Barrigel Injectable Gel
Applicant
Palette Life Sciences
27 E Cota St.
Suite 402
Santa Barbara,  CA  93101
Applicant Contact David Goodnough
Correspondent
Palette Life Sciences
27 E Cota St.
Suite 402
Santa Barbara,  CA  93101
Correspondent Contact David Goodnough
Regulation Number892.5725
Classification Product Code
OVB  
Date Received03/04/2022
Decision Date 05/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT04189913
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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