The following data is part of a premarket notification filed by Inter-med, Inc. with the FDA for Sodium Hypochlorite 3 & 6% Solution And 6% With Wetting Agents To Lower Surface Tension Marketed As Chlor-xtra.
| Device ID | K082470 |
| 510k Number | K082470 |
| Device Name: | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA |
| Classification | Cleanser, Root Canal |
| Applicant | INTER-MED, INC. 2200 NORTHWESTERN AVE. Racine, WI 53404 |
| Contact | George Horvat |
| Correspondent | George Horvat INTER-MED, INC. 2200 NORTHWESTERN AVE. Racine, WI 53404 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-27 |
| Decision Date | 2009-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889813028070 | K082470 | 000 |
| 10818207020618 | K082470 | 000 |
| 10818207020397 | K082470 | 000 |
| 10818207020403 | K082470 | 000 |
| 10818207020410 | K082470 | 000 |
| 10818207020427 | K082470 | 000 |
| 10818207020434 | K082470 | 000 |
| 10818207020441 | K082470 | 000 |
| 10818207020458 | K082470 | 000 |
| 10818207020465 | K082470 | 000 |
| 10818207020472 | K082470 | 000 |
| 10818207020489 | K082470 | 000 |
| 10818207020496 | K082470 | 000 |
| 10818207020502 | K082470 | 000 |
| H658711265161 | K082470 | 000 |
| 10818207020601 | K082470 | 000 |