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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K203803
Device Name VASOBand Vascular Compression Device
Applicant
VASOInnovations, Inc
1260 Huntington Drive
Suite 208
South Pasadena,  CA  91030
Applicant Contact Rajendra Gurudas Sardesai
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.4450
Classification Product Code
DXC  
Date Received12/28/2020
Decision Date 01/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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