The following data is part of a premarket notification filed by Scion Cardio-vascular, Inc. with the FDA for Clo-surplus P.a.d..
| Device ID | K092552 |
| 510k Number | K092552 |
| Device Name: | CLO-SURPLUS P.A.D. |
| Classification | Dressing, Wound, Drug |
| Applicant | SCION CARDIO-VASCULAR, INC. 14256 SW 119TH AVE. Miami, FL 33186 |
| Contact | Dennis Hammond |
| Correspondent | Dennis Hammond SCION CARDIO-VASCULAR, INC. 14256 SW 119TH AVE. Miami, FL 33186 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-08-20 |
| Decision Date | 2009-09-04 |
| Summary: | summary |