The following data is part of a premarket notification filed by Specialty Surgical Products, Inc. with the FDA for Silicone Tissue/inflatable Tissue Expander.
| Device ID | K974209 |
| 510k Number | K974209 |
| Device Name: | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Contact | Jan Varner |
| Correspondent | Jan Varner SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| 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 | 1997-11-10 |
| Decision Date | 1998-02-06 |