The following data is part of a premarket notification filed by Sterile Concepts, Inc. with the FDA for Dentist With Assistant Pack.
| Device ID | K940864 |
| 510k Number | K940864 |
| Device Name: | DENTIST WITH ASSISTANT PACK |
| Classification | Unit, Operative Dental |
| Applicant | STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-23 |
| Decision Date | 1994-08-02 |