The following data is part of a premarket notification filed by Bd with the FDA for Bd Surgiphor™ Antimicrobial Irrigation System.
| Device ID | K221504 |
| 510k Number | K221504 |
| Device Name: | BD Surgiphor™ Antimicrobial Irrigation System |
| Classification | Lavage, Jet |
| Applicant | BD 75 N Fairway Dr Vernon Hills, IL 60061 |
| Contact | Shelley Wilcox |
| Correspondent | Shelley Wilcox BD 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 | 2022-05-23 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382909101107 | K221504 | 000 |