PuraSinus
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
3-D Matrix, Inc.
The following data is part of a premarket notification filed by 3-d Matrix, Inc. with the FDA for Purasinus.
Pre-market Notification Details
| Device ID | K183015 |
| 510k Number | K183015 |
| Device Name: | PuraSinus |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | 3-D Matrix, Inc. 250 First Ave., Suite 205 Needham, MA 02494 |
| Contact | Lisa Spirio |
| Correspondent | Stephen P. Rhodes Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-31 |
| Decision Date | 2019-04-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001820843 | K183015 | 000 |
| 00860001820836 | K183015 | 000 |
| 00860001820829 | K183015 | 000 |
| 00860007400315 | K183015 | 000 |
| 00860007400308 | K183015 | 000 |
| 00860001820898 | K183015 | 000 |
Trademark Results [PuraSinus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURASINUS 88388156 not registered Live/Pending |
3-D Matrix, Ltd. 2019-04-16 |
 PURASINUS 88179624 not registered Live/Pending |
3-D Matrix, Ltd. 2018-11-02 |
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