The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Cutter Flex-silicone Impression Mat..
| Device ID | K760752 |
| 510k Number | K760752 |
| Device Name: | CUTTER FLEX-SILICONE IMPRESSION MAT. |
| Classification | Material, Impression |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-01 |
| Decision Date | 1976-10-15 |