Promogran Matrix Wound Dressing
FDA 510(k) K014129 · Johnson & Johnson Medical, Ltd.
510(k) numberK014129
Submission
- Device name
- Promogran Matrix Wound Dressing
- Applicant
- Johnson & Johnson Medical, Ltd.
Somerville, NJ, US - Received
- December 17, 2001
- Decision date
- February 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
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| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | 05/18/1998SE |
| K980493 | I.V. Catheter SystemFOZ · Traditional | 04/28/1998SE |
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Questions and answers
When was Promogran Matrix Wound Dressing cleared by the FDA?
Promogran Matrix Wound Dressing (K014129) received a 510(k) decision of Substantially Equivalent on February 14, 2002, 59 days after the submission was received.
What is the product code of K014129?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.