The following data is part of a premarket notification filed by E.m. Adams with the FDA for Incision & Drainage Tray.
| Device ID | K812134 |
| 510k Number | K812134 |
| Device Name: | INCISION & DRAINAGE TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | E.M. ADAMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-28 |
| Decision Date | 1982-01-15 |