The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Coe Pak Auto Mix, Regular Or Hard Set.
| Device ID | K881422 |
| 510k Number | K881422 |
| Device Name: | COE PAK AUTO MIX, REGULAR OR HARD SET |
| Classification | Cement, Dental |
| Applicant | COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Contact | Brahma D Sharma,phd |
| Correspondent | Brahma D Sharma,phd COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-05 |
| Decision Date | 1988-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040000321 | K881422 | 000 |
| 20386040000311 | K881422 | 000 |
| 20386040000304 | K881422 | 000 |