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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 K213385
Device Name GEM
Applicant
Obsidio, Inc.
1520 Main Street, Unit 4-C
Columbia,  SC  29201
Applicant Contact Ehsan Jabbarzadeh
Correspondent
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Heidi Shearer
Regulation Number870.3300
Classification Product Code
KRD  
Date Received10/13/2021
Decision Date 07/01/2022
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
Recalls CDRH Recalls
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