The following data is part of a premarket notification filed by Twin City Surgical, Inc. with the FDA for The (crom) Tester.
| Device ID | K870767 |
| 510k Number | K870767 |
| Device Name: | THE (CROM) TESTER |
| Classification | Goniometer, Nonpowered |
| Applicant | TWIN CITY SURGICAL, INC. 2800 N.FAIRVIEW AVE. St. Paul, MN 55113 |
| Contact | Wayne O Duescher |
| Correspondent | Wayne O Duescher TWIN CITY SURGICAL, INC. 2800 N.FAIRVIEW AVE. St. Paul, MN 55113 |
| Product Code | KQW |
| CFR Regulation Number | 888.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-03-17 |