The following data is part of a premarket notification filed by Inovativ, Llc with the FDA for Acetal.
| Device ID | K022032 |
| 510k Number | K022032 |
| Device Name: | ACETAL |
| Classification | Clasp, Preformed |
| Applicant | INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson, OR 97352 |
| Contact | Robert Bowers |
| Correspondent | Robert Bowers INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson, OR 97352 |
| Product Code | EHP |
| CFR Regulation Number | 872.3285 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-08-29 |
| Summary: | summary |