CLO-SURPLUS P.A.D.
Device Facts
| Record ID | K092552 |
|---|---|
| Device Name | CLO-SURPLUS P.A.D. |
| Applicant | Scion Cardio-Vascular, Inc. |
| Product Code | QSY · SU |
| Decision Date | Sep 4, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Regulatory Classification
Identification
To temporarily control bleeding and cover external wounds.
Submission Summary (Full Text)
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Scion Cardio-Vascular, Inc. c/o Dennis Hammond Director QA/RA 14256 SW 119th Ave. Miami. Florida 33186
July 28, 2023
Re: K092552 Trade/Device Name: Clo-SurPLUS P.A.D. Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Dennis Hammond:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 4, 2009. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
