The following data is part of a premarket notification filed by Inamed Development Co. with the FDA for Inamed Ruiz-cohen Intraoperative Tissue Expander.
| Device ID | K904265 |
| 510k Number | K904265 |
| Device Name: | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | INAMED DEVELOPMENT CO. 1035 A. CINDY LN. Carpinteria, CA 93013 |
| Contact | Ellen Duke |
| Correspondent | Ellen Duke INAMED DEVELOPMENT CO. 1035 A. CINDY LN. Carpinteria, CA 93013 |
| 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 | 1990-09-18 |
| Decision Date | 1991-03-06 |