The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Prontosan Wound Irrigation Solution, 40 Ml, Prontosan Wound Irrigation Solution, 350 Ml, Prontosan Wound Irrigation Solution, 1000 Ml.
| Device ID | K161623 |
| 510k Number | K161623 |
| Device Name: | Prontosan Wound Irrigation Solution, 40 ML, Prontosan Wound Irrigation Solution, 350 ML, Prontosan Wound Irrigation Solution, 1000 ML |
| Classification | Dressing, Wound, Drug |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
| Contact | Nancy Skocypec |
| Correspondent | Nancy Skocypec B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-06-13 |
| Decision Date | 2016-11-10 |
| Summary: | summary |