The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Tum-e-vac Bite Block.
| Device ID | K921946 |
| 510k Number | K921946 |
| Device Name: | TUM-E-VAC BITE BLOCK |
| Classification | Block, Bite |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | Robert J Hein |
| Correspondent | Robert J Hein ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1992-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483150037 | K921946 | 000 |