COMPEL XTR
Gown, Surgical
STANDARD TEXTILE CO., INC.
The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Compel Xtr.
Pre-market Notification Details
| Device ID | K922753 |
| 510k Number | K922753 |
| Device Name: | COMPEL XTR |
| Classification | Gown, Surgical |
| Applicant | STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Contact | Bradley J Bushman |
| Correspondent | Bradley J Bushman STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1993-03-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634916295108 | K922753 | 000 |
| 00634916230017 | K922753 | 000 |
| 00634916089561 | K922753 | 000 |
| 00634916046427 | K922753 | 000 |
| 00634916040036 | K922753 | 000 |
| 00634916024463 | K922753 | 000 |
| 00634916005882 | K922753 | 000 |
| 00634916005875 | K922753 | 000 |
Trademark Results [COMPEL XTR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMPEL XTR 74442568 1920796 Live/Registered |
Standard Textile Co., Inc. 1993-09-30 |
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