Last synced on 2 December 2022 at 11:04 pm

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Ca

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192468
510(k) Type
Traditional
Applicant
Hangzhou Bever Medical Devices Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/27/2019
Days to Decision
79 days
Submission Type
Summary

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Ca

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192468
510(k) Type
Traditional
Applicant
Hangzhou Bever Medical Devices Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/27/2019
Days to Decision
79 days
Submission Type
Summary