The following data is part of a premarket notification filed by A Company, Inc. with the FDA for A-company Elastomeric Tubing.
| Device ID | K852599 |
| 510k Number | K852599 |
| Device Name: | A-COMPANY ELASTOMERIC TUBING |
| Classification | Band, Elastic, Orthodontic |
| Applicant | A COMPANY, INC. 11436 SORRENTO VALLEY RD. POST OFFICE BOX 81247 San Diego, CA 92138 |
| Contact | Joe Monfredo |
| Correspondent | Joe Monfredo A COMPANY, INC. 11436 SORRENTO VALLEY RD. POST OFFICE BOX 81247 San Diego, CA 92138 |
| Product Code | ECI |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-19 |
| Decision Date | 1985-07-31 |