The following data is part of a premarket notification filed by David F. Trungale with the FDA for Si-pro.
| Device ID | K904389 |
| 510k Number | K904389 |
| Device Name: | SI-PRO |
| Classification | Protector, Wound, Plastic |
| Applicant | DAVID F. TRUNGALE 16720 ROSEWOOD CT. Brookfield, WI 53005 |
| Contact | David F Trunagle |
| Correspondent | David F Trunagle DAVID F. TRUNGALE 16720 ROSEWOOD CT. Brookfield, WI 53005 |
| Product Code | EYF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-26 |
| Decision Date | 1990-12-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SI-PRO 87399782 not registered Dead/Abandoned |
ARC-COM FABRICS, INC. 2017-04-05 |