NuStat
Temporary, Internal Use Hemostatic
Beeken Biomedical, LLC
The following data is part of a premarket notification filed by Beeken Biomedical, Llc with the FDA for Nustat.
Pre-market Notification Details
| Device ID | K183190 |
| 510k Number | K183190 |
| Device Name: | NuStat |
| Classification | Temporary, Internal Use Hemostatic |
| Applicant | Beeken Biomedical, LLC 378 Page St, Suite 201 Stoughton, MA 02072 |
| Contact | Richard A. Kendall |
| Correspondent | Mary Mcnamara Alira Health 1 Grant Street, Suite 400 Framingham, MA 01702 |
| Product Code | POD |
| CFR Regulation Number | 878.4454 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-09-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850392006704 | K183190 | 000 |
| 00850392006605 | K183190 | 000 |
| 00850392006599 | K183190 | 000 |
| 00850392006544 | K183190 | 000 |
| 00850392006506 | K183190 | 000 |
| 00850392006179 | K183190 | 000 |
| 10850392006169 | K183190 | 000 |
Trademark Results [NuStat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUSTAT 85885639 4548880 Live/Registered |
Beeken BioMedical, LLC 2013-03-25 |
 NUSTAT 73720384 1517081 Dead/Cancelled |
HASSIDIM, YAACOV 1988-04-04 |
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