The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Stat.br Tm.
| Device ID | K904482 |
| 510k Number | K904482 |
| Device Name: | STAT.BR TM |
| Classification | Material, Impression |
| Applicant | KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174 |
| Contact | Benjamin Weaver |
| Correspondent | Benjamin Weaver KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1990-11-29 |