The following data is part of a premarket notification filed by Specialty Surgical Products, Inc. with the FDA for Allox2 Tissue Expanders.
| Device ID | K140383 |
| 510k Number | K140383 |
| Device Name: | ALLOX2 TISSUE EXPANDERS |
| Classification | Expander, Skin, Inflatable |
| Applicant | SPECIALTY SURGICAL PRODUCTS, INC. 1123 NORTH U.S. HWY. 93 Victor, MT 59875 |
| Contact | Sherry Null |
| Correspondent | Sherry Null SPECIALTY SURGICAL PRODUCTS, INC. 1123 NORTH U.S. HWY. 93 Victor, MT 59875 |
| 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 | 2014-02-14 |
| Decision Date | 2014-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819409020409 | K140383 | 000 |
| 00812790028290 | K140383 | 000 |
| 00812790028283 | K140383 | 000 |
| 00812790028276 | K140383 | 000 |
| 00812790028269 | K140383 | 000 |
| 00812790028252 | K140383 | 000 |
| 00812790028245 | K140383 | 000 |
| 00812790028238 | K140383 | 000 |
| 00812790028221 | K140383 | 000 |
| 00812790028214 | K140383 | 000 |
| 00812790028207 | K140383 | 000 |
| 00812790028306 | K140383 | 000 |
| 00812790028313 | K140383 | 000 |
| 00819409020355 | K140383 | 000 |
| 00812790028405 | K140383 | 000 |
| 00812790028399 | K140383 | 000 |
| 00812790028382 | K140383 | 000 |
| 00812790028375 | K140383 | 000 |
| 00812790028368 | K140383 | 000 |
| 00812790028351 | K140383 | 000 |
| 00812790028344 | K140383 | 000 |
| 00812790028337 | K140383 | 000 |
| 00812790028320 | K140383 | 000 |
| 00812790028191 | K140383 | 000 |