The following data is part of a premarket notification filed by Megaplast, Inc. with the FDA for Suture Removal Tray.
| Device ID | K820423 |
| 510k Number | K820423 |
| Device Name: | SUTURE REMOVAL TRAY |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | MEGAPLAST, 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 | 1982-02-16 |
| Decision Date | 1982-03-10 |