The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Incision & Drain Set.
| Device ID | K813103 |
| 510k Number | K813103 |
| Device Name: | ACKRAD INCISION & DRAIN SET |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | ACKRAD LABORATORIES 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 | 1981-11-03 |
| Decision Date | 1981-12-09 |