The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Tissue Expander.
| Device ID | K981852 |
| 510k Number | K981852 |
| Device Name: | SILIMED TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | SILIMED, LLC. P.O BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith SILIMED, LLC. P.O BOX 4341 Crofton, MD 21114 |
| 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 | 1998-05-26 |
| Decision Date | 1998-08-05 |