The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Silastic Soft Sheeting.
| Device ID | K894226 |
| 510k Number | K894226 |
| Device Name: | SILASTIC SOFT SHEETING |
| Classification | Dressing, Wound, Drug |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Micki Roy |
| Correspondent | Micki Roy DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| 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 | 1989-06-19 |
| Decision Date | 1990-01-03 |