The following data is part of a premarket notification filed by Cambridgemed with the FDA for Clearadex Gel.
| Device ID | K060561 |
| 510k Number | K060561 |
| Device Name: | CLEARADEX GEL |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | CAMBRIDGEMED 800 WEST CUMMINGS PARK SUITE 2900 Woburn, MA 01801 |
| Contact | Paul Strati |
| Correspondent | Paul Strati CAMBRIDGEMED 800 WEST CUMMINGS PARK SUITE 2900 Woburn, MA 01801 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-03 |
| Decision Date | 2006-05-30 |