The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Tum-e-vac.
| Device ID | K962850 |
| 510k Number | K962850 |
| Device Name: | TUM-E-VAC |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | John A Young |
| Correspondent | John A Young 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 | 1996-07-22 |
| Decision Date | 1997-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483150167 | K962850 | 000 |
| 20889483150075 | K962850 | 000 |
| 20889483150068 | K962850 | 000 |
| 20889483150051 | K962850 | 000 |
| 20889483150044 | K962850 | 000 |
| 20889483131098 | K962850 | 000 |
| 20889483130954 | K962850 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TUM-E-VAC 74033252 1619710 Live/Registered |
Ethox Corp. 1990-02-28 |