The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Surgiphor Antimicrobial Irrigation System.
Device ID | K213616 |
510k Number | K213616 |
Device Name: | BD Surgiphor Antimicrobial Irrigation System |
Classification | Lavage, Jet |
Applicant | Becton, Dickinson And Company 75 N Fairway Dr Vernon Hills, IL 60061 |
Contact | Shelley Wilcox |
Correspondent | Shelley Wilcox Becton, Dickinson And Company 75 N Fairway Dr Vernon Hills, IL 60061 |
Product Code | FQH |
CFR Regulation Number | 880.5475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2021-11-15 |
Decision Date | 2022-03-23 |