The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Memosil C.d..
| Device ID | K913537 |
| 510k Number | K913537 |
| Device Name: | MEMOSIL C.D. |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205015624 | K913537 | 000 |
| J011164000000 | K913537 | 000 |