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 |