The following data is part of a premarket notification filed by Inter-med, Inc. with the FDA for Chx=chx Plus.
| Device ID | K112250 |
| 510k Number | K112250 |
| Device Name: | CHX=CHX PLUS |
| Classification | Cleanser, Root Canal |
| Applicant | INTER-MED, INC. 2200 NORTHWESTERN AVE. Racine, WI 53404 |
| Contact | John Baeten |
| Correspondent | John Baeten 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 | Yes |
| Date Received | 2011-08-04 |
| Decision Date | 2011-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818207020373 | K112250 | 000 |
| 10818207020281 | K112250 | 000 |
| 10818207020298 | K112250 | 000 |
| 10818207020304 | K112250 | 000 |
| 10818207020311 | K112250 | 000 |
| 10818207020328 | K112250 | 000 |
| 10818207020335 | K112250 | 000 |
| 10818207020342 | K112250 | 000 |
| 10818207020359 | K112250 | 000 |
| 10818207020366 | K112250 | 000 |
| 10818207020595 | K112250 | 000 |