The following data is part of a premarket notification filed by Aukland Medical Plastics, Inc. with the FDA for Aukusleeve.
| Device ID | K930094 |
| 510k Number | K930094 |
| Device Name: | AUKUSLEEVE |
| Classification | Handle, Instrument, Dental |
| Applicant | AUKLAND MEDICAL PLASTICS, INC. P.O. BOX 5624 Cary, NC 27512 |
| Contact | Norman A Gray |
| Correspondent | Norman A Gray AUKLAND MEDICAL PLASTICS, INC. P.O. BOX 5624 Cary, NC 27512 |
| Product Code | EJB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-08 |
| Decision Date | 1993-10-20 |