The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Radovan Tissue Expander.
| Device ID | K842883 |
| 510k Number | K842883 |
| Device Name: | RADOVAN TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| 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 | 1984-07-23 |
| Decision Date | 1984-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317002598 | K842883 | 000 |
| 00081317002468 | K842883 | 000 |
| 00081317002451 | K842883 | 000 |
| 00081317002444 | K842883 | 000 |
| 00081317002437 | K842883 | 000 |
| 00081317002420 | K842883 | 000 |
| 00081317002413 | K842883 | 000 |
| 00081317002406 | K842883 | 000 |
| 00081317002390 | K842883 | 000 |
| 00081317002383 | K842883 | 000 |
| 00081317002475 | K842883 | 000 |
| 00081317002482 | K842883 | 000 |
| 00081317002499 | K842883 | 000 |
| 00081317002581 | K842883 | 000 |
| 00081317002574 | K842883 | 000 |
| 00081317002567 | K842883 | 000 |
| 00081317002550 | K842883 | 000 |
| 00081317002543 | K842883 | 000 |
| 00081317002536 | K842883 | 000 |
| 00081317002529 | K842883 | 000 |
| 00081317002512 | K842883 | 000 |
| 00081317002505 | K842883 | 000 |
| 00081317002376 | K842883 | 000 |