The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Radovan Tissue Expander (option Integral Inject.).
| Device ID | K884250 |
| 510k Number | K884250 |
| Device Name: | RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Byron Wickett |
| Correspondent | Byron Wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| 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 | 1988-10-11 |
| Decision Date | 1989-06-12 |