Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414
FDA 510(k) K012816 · Dynarex Corp.
510(k) numberK012816
Submission
- Device name
- Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414
- Applicant
- Dynarex Corp.
Maineville, OH, US - Received
- August 22, 2001
- Decision date
- October 17, 2002
- 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 Iodoform Packing Strips, Models 3411, 3412, 3413, 3414 cleared by the FDA?
Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414 (K012816) received a 510(k) decision of Substantially Equivalent on October 17, 2002, 421 days after the submission was received.
What is the product code of K012816?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.