The following data is part of a premarket notification filed by Sterile Concepts, Inc. with the FDA for Dental Hygiene Tray.
| Device ID | K944139 |
| 510k Number | K944139 |
| Device Name: | DENTAL HYGIENE TRAY |
| Classification | Latex Patient Examination Glove |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-24 |
| Decision Date | 1994-12-15 |