The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Eye Dressing.
Device ID | K923300 |
510k Number | K923300 |
Device Name: | DEROYAL EYE DRESSING |
Classification | Tape And Bandage, Adhesive |
Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
Contact | Debra F Manning |
Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-06 |
Decision Date | 1992-09-01 |