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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K240873
Device Name TEMBO Embolic System
Applicant
Instylla, Inc.
201 Burlington Rd
North Building
Bedford,  MA  01730
Applicant Contact Jennifer Greer
Correspondent
Instylla, Inc.
201 Burlington Rd
North Building
Bedford,  MA  01730
Correspondent Contact Jennifer Greer
Regulation Number870.3300
Classification Product Code
KRD  
Date Received03/29/2024
Decision Date 12/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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