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 |