StimSite
Stimulator, Nerve
Allotrope Medical Inc
The following data is part of a premarket notification filed by Allotrope Medical Inc with the FDA for Stimsite.
Pre-market Notification Details
| Device ID | K200886 |
| 510k Number | K200886 |
| Device Name: | StimSite |
| Classification | Stimulator, Nerve |
| Applicant | Allotrope Medical Inc 2450 Holcombe Blvd., Suite J Houston, TX 77021 |
| Contact | Albert Huang |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-02 |
| Decision Date | 2020-11-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002926957 | K200886 | 000 |
| 00860002926940 | K200886 | 000 |
| 00860002926933 | K200886 | 000 |
| 00860002926919 | K200886 | 000 |
| 00860002926902 | K200886 | 000 |
| 00817183020776 | K200886 | 000 |
Trademark Results [StimSite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIMSITE 90094944 not registered Live/Pending |
Allotrope Medical, Inc. 2020-08-05 |
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