TRACH-ASSIST
Connector, Airway (extension)
MERGENET MEDICAL
The following data is part of a premarket notification filed by Mergenet Medical with the FDA for Trach-assist.
Pre-market Notification Details
| Device ID | K083702 |
| 510k Number | K083702 |
| Device Name: | TRACH-ASSIST |
| Classification | Connector, Airway (extension) |
| Applicant | MERGENET MEDICAL 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MERGENET MEDICAL 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-03-05 |
| Summary: | summary |
Trademark Results [TRACH-ASSIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACH-ASSIST 77608876 3838546 Dead/Cancelled |
Mergenet Medical, Inc. 2008-11-06 |
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