The following data is part of a premarket notification filed by Barrier Concepts, Inc. with the FDA for Allpac(tm) Material.
| Device ID | K894759 |
| 510k Number | K894759 |
| Device Name: | ALLPAC(TM) MATERIAL |
| Classification | Unit, Operative Dental |
| Applicant | BARRIER CONCEPTS, INC. POST OFFICE BOX 11421 Columbia, SC 29211 |
| Contact | C Hasterok |
| Correspondent | C Hasterok BARRIER CONCEPTS, INC. POST OFFICE BOX 11421 Columbia, SC 29211 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-10-13 |