4DDOME
Mesh, Surgical, Polymeric
COUSIN BIOTECH
The following data is part of a premarket notification filed by Cousin Biotech with the FDA for 4ddome.
Pre-market Notification Details
| Device ID | K070918 |
| 510k Number | K070918 |
| Device Name: | 4DDOME |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | COUSIN BIOTECH 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden COUSIN BIOTECH 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-08-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760185572941 | K070918 | 000 |
| 03760185572934 | K070918 | 000 |
| 03760185572927 | K070918 | 000 |
| 03760185572361 | K070918 | 000 |
| 03760185572347 | K070918 | 000 |
| 03760185572323 | K070918 | 000 |
Trademark Results [4DDOME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 4DDOME 77222044 3465944 Dead/Cancelled |
COUSIN BIOTECH 2007-07-04 |
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