The following data is part of a premarket notification filed by Think Surgical, Inc. with the FDA for Tcat Tka Instrument Tray Set.
| Device ID | K200632 |
| 510k Number | K200632 |
| Device Name: | TCAT TKA Instrument Tray Set |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | THINK Surgical, Inc. 47201 Lakeview Blvd Fremont, CA 94538 |
| Contact | George J. Prendergast |
| Correspondent | George J. Prendergast THINK Surgical, Inc. 47201 Lakeview Blvd Fremont, CA 94538 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-04-08 |