The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Transparent Film Dressign.
Device ID | K920796 |
510k Number | K920796 |
Device Name: | DEROYAL TRANSPARENT FILM DRESSIGN |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
Contact | Debra Manning |
Correspondent | Debra Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-21 |
Decision Date | 1992-07-23 |