Dynarex Xeroform Petrolatum Dressing
FDA 510(k) K152970 · Dynarex Corporation
510(k) numberK152970
Submission
- Device name
- Dynarex Xeroform Petrolatum Dressing
- Applicant
- Dynarex Corporation
Orangeburg, NY, US - Received
- October 8, 2015
- Decision date
- October 3, 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 Dynarex Xeroform Petrolatum Dressing cleared by the FDA?
Dynarex Xeroform Petrolatum Dressing (K152970) received a 510(k) decision of Substantially Equivalent on October 3, 2016, 361 days after the submission was received.
What is the product code of K152970?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.