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 Number | 876.5130
|
Classification Product Code |
|
Date Received | 03/03/2020 |
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
|
|
|