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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K190492
Device Name Peralta Stone Removal Catheter
Applicant
Calcula Technologies, Inc.
959 Peralta Ave.
San Francisco,  CA  94110
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 Number876.4680
Classification Product Code
FFL  
Subsequent Product Code
EZN  
Date Received02/28/2019
Decision Date 07/18/2019
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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