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 | K112961 |
| 510k Number | K112961 |
| Device Name: | CLO-SURPLUS P.A.D. |
| Classification | Dressing, Wound, Drug |
| Applicant | SCION CARDIO-VASCULAR, INC. 1050 W NASA BLVD # 136 Melbourne, FL 32901 |
| Contact | Craig Pagan |
| Correspondent | Craig Pagan SCION CARDIO-VASCULAR, INC. 1050 W NASA BLVD # 136 Melbourne, FL 32901 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2011-10-31 |
| Summary: | summary |