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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K203529
Device Name VASSALLO GT Hybrid
Applicant
Filmecc Co., Ltd.
1703 Wakita-Cho, Moriyama-Ku
Hagoya-Shi,  JP 463-0024
Applicant Contact Toshiya Osawa
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annapolis,  MD  21401
Correspondent Contact Candace Cederman
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/02/2020
Decision Date 05/04/2021
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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