Topseal Hemostatic Dressing, Model 11150
FDA 510(k) K033291 · Radi Medical Systems AB
510(k) numberK033291
Submission
- Device name
- Topseal Hemostatic Dressing, Model 11150
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- October 14, 2003
- Decision date
- March 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device class
- Unclassified
To temporarily control bleeding and cover external wounds.
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Questions and answers
When was Topseal Hemostatic Dressing, Model 11150 cleared by the FDA?
Topseal Hemostatic Dressing, Model 11150 (K033291) received a 510(k) decision of Substantially Equivalent on March 17, 2004, 155 days after the submission was received.
What is the product code of K033291?
The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.