The following data is part of a premarket notification filed by Enterix Inc. with the FDA for Insure Ii.
| Device ID | K060930 |
| 510k Number | K060930 |
| Device Name: | INSURE II |
| Classification | Reagent, Occult Blood |
| Applicant | ENTERIX INC. 236 FERNWOOD AVE. Edison, NJ 08837 |
| Contact | Edwin Diaz |
| Correspondent | Edwin Diaz ENTERIX INC. 236 FERNWOOD AVE. Edison, NJ 08837 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-05 |
| Decision Date | 2006-05-04 |