The following data is part of a premarket notification filed by Scion Cardio-vascular, Inc. with the FDA for Clo-surplusp.a.d..
| Device ID | K032986 |
| 510k Number | K032986 |
| Device Name: | CLO-SURPLUSP.A.D. |
| Classification | Dressing, Wound, Drug |
| Applicant | SCION CARDIO-VASCULAR, INC. 14256 SW 119 AVE. Miami, FL 33186 |
| Contact | Ramon Augusto Paz |
| Correspondent | Ramon Augusto Paz SCION CARDIO-VASCULAR, INC. 14256 SW 119 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 | No |
| Date Received | 2003-09-24 |
| Decision Date | 2004-03-01 |
| Summary: | summary |