Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
FDA 510(k) K161623 · B.Braun Medical, Inc.
510(k) numberK161623
Submission
- Device name
- Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- June 13, 2016
- Decision date
- November 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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Questions and answers
When was Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL cleared by the FDA?
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL (K161623) received a 510(k) decision of Substantially Equivalent on November 10, 2016, 150 days after the submission was received.
What is the product code of K161623?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.