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 |