Modular Toga
Gown, Surgical
Operating Room Innovations, Inc.
The following data is part of a premarket notification filed by Operating Room Innovations, Inc. with the FDA for Modular Toga.
Pre-market Notification Details
| Device ID | K200977 |
| 510k Number | K200977 |
| Device Name: | Modular Toga |
| Classification | Gown, Surgical |
| Applicant | Operating Room Innovations, Inc. 5694 Mission Center Road Ste 602 San Diego, CA 92108 |
| Contact | Mark Mcbride |
| Correspondent | Glen Feye Accurate Consultants, Inc 3234 Ibis Street San Diego, CA 92103 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-13 |
| Decision Date | 2020-08-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854150007330 | K200977 | 000 |
| 00854150007316 | K200977 | 000 |
Trademark Results [Modular Toga]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MODULAR TOGA 97384175 not registered Live/Pending |
Operating Room Innovations, Inc. 2022-04-27 |
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