The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Ethox Lavage Tube.
| Device ID | K860599 |
| 510k Number | K860599 |
| Device Name: | ETHOX LAVAGE TUBE |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | Frank P Wilton |
| Correspondent | Frank P Wilton ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483149782 | K860599 | 000 |
| 20889483131142 | K860599 | 000 |
| 20889483131135 | K860599 | 000 |
| 20889483130961 | K860599 | 000 |