The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Gowns, Sterile, Non-sterile.
Device ID | K030364 |
510k Number | K030364 |
Device Name: | DEROYAL GOWNS, STERILE, NON-STERILE |
Classification | Gown, Surgical |
Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
Contact | Audrey Daniels |
Correspondent | Audrey Daniels DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
Product Code | FYA |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-04 |
Decision Date | 2003-04-28 |