HYLASINE
Balloon, Epistaxis
BIOMATRIX, INC.
The following data is part of a premarket notification filed by Biomatrix, Inc. with the FDA for Hylasine.
Pre-market Notification Details
| Device ID | K993362 |
| 510k Number | K993362 |
| Device Name: | HYLASINE |
| Classification | Balloon, Epistaxis |
| Applicant | BIOMATRIX, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 |
| Contact | Mario J Reres |
| Correspondent | Mario J Reres BIOMATRIX, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-06 |
| Decision Date | 2000-03-13 |
| Summary: | summary |
Trademark Results [HYLASINE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYLASINE 75559720 not registered Dead/Abandoned |
GENZYME BIOSURGERY CORPORATION 1998-09-25 |
 HYLASINE 74580116 not registered Dead/Abandoned |
Biomatrix, Inc. 1994-09-29 |
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