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 |