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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K202566
Device Name Wiygul Catheter
Applicant
Big Blue Biotech, Inc.
690 Canton Street, Suite 302
Westwood,  MA  02090
Applicant Contact Russ Olsen
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number876.5130
Classification Product Code
EZD  
Date Received09/04/2020
Decision Date 09/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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