The following data is part of a premarket notification filed by Surgitek with the FDA for Tissue Expander.
| Device ID | K840464 |
| 510k Number | K840464 |
| Device Name: | TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | SURGITEK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-03 |
| Decision Date | 1984-03-12 |