The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for C-section Tray.
Device ID | K842627 |
510k Number | K842627 |
Device Name: | C-SECTION TRAY |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | DEROYAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-06 |
Decision Date | 1984-09-26 |