The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Endocyn Root Canal Irrigation Solution.
| Device ID | K141352 |
| 510k Number | K141352 |
| Device Name: | ENDOCYN ROOT CANAL IRRIGATION SOLUTION |
| Classification | Cleanser, Root Canal |
| Applicant | OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD Petaluma, CA 94954 |
| Contact | Brian W Martin |
| Correspondent | Brian W Martin OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD Petaluma, CA 94954 |
| 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 | 2014-05-23 |
| Decision Date | 2014-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850015491614 | K141352 | 000 |
| 20850015491164 | K141352 | 000 |
| 20850015491157 | K141352 | 000 |
| 20850015491140 | K141352 | 000 |