The following data is part of a premarket notification filed by Trent Wells, Inc. with the FDA for Brown-roberts-wells Stereotaxic Sytem.
| Device ID | K811452 |
| 510k Number | K811452 |
| Device Name: | BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | TRENT WELLS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-22 |
| Decision Date | 1981-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M248SCSWCD1 | K811452 | 000 |