The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Rapid Hb, Rapid Lb, Rapid Mb.
| Device ID | K173318 |
| 510k Number | K173318 |
| Device Name: | Rapid HB, Rapid LB, Rapid MB |
| Classification | Material, Impression |
| Applicant | 3M Deutschland GmbH ESPE Platz Seefeld, DE 82229 |
| Contact | Ruediger Franke |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-10-20 |
| Decision Date | 2017-10-31 |
| Summary: | summary |