The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Miracle Mix Capsule.
| Device ID | K981370 |
| 510k Number | K981370 |
| Device Name: | MIRACLE MIX CAPSULE |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-15 |
| Decision Date | 1998-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386040010743 | K981370 | 000 |
| 10386040010733 | K981370 | 000 |
| 00386040010644 | K981370 | 000 |