The following data is part of a premarket notification filed by Thompson Surgical Instruments Inc. with the FDA for Thompson Brain Retractor Table Mounted (tm), Thompson Brain Retractor Skull Clamp Mounted (scm).
| Device ID | K210615 |
| 510k Number | K210615 |
| Device Name: | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | Thompson Surgical Instruments Inc. 10341 E Cherry Bend Rd Traverse, MI 49684 |
| Contact | Tiffany Irwin |
| Correspondent | Tiffany Bush Thompson Surgical Instruments Inc. 10341 E Cherry Bend Rd Traverse, MI 49684 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841536118582 | K210615 | 000 |
| 00841536118575 | K210615 | 000 |
| 00841536118599 | K210615 | 000 |
| 00841536118605 | K210615 | 000 |
| 00841536133424 | K210615 | 000 |
| 00841536133431 | K210615 | 000 |
| 00841536133448 | K210615 | 000 |
| 00841536133455 | K210615 | 000 |
| 00841536133462 | K210615 | 000 |
| 00841536134230 | K210615 | 000 |
| 00841536118568 | K210615 | 000 |