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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 K200556
Device Name AquaFlate Pre-Filled Sterile Water Syringe 10mL
Applicant
HR Pharmaceuticals, Inc.
2600 Eastern Boulevard, Suite 201
york,  PA  17402
Applicant Contact colby wiesman
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/03/2020
Decision Date 03/31/2020
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
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