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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K182635
Device Name Signal Catheter
Applicant
Safe Medical Design
2722 Fulton St.
San Francisco,  CA  94118
Applicant Contact Raymond "Buzz" Bonneau
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/24/2018
Decision Date 01/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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