The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Cui, Versafil(tm), Ste(tm) Tissue Expander.
| Device ID | K874276 |
| 510k Number | K874276 |
| Device Name: | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | COX-UPHUFF INTL. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Contact | J Schuessler |
| Correspondent | J Schuessler COX-UPHUFF INTL. P.O. BOX 40288 Santa Barbara, CA 93140 |
| 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 | 1987-10-20 |
| Decision Date | 1987-12-02 |