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 |