The following data is part of a premarket notification filed by Health Technology Systems, Inc. with the FDA for Dental Needle Protective System.
| Device ID | K910475 |
| 510k Number | K910475 |
| Device Name: | DENTAL NEEDLE PROTECTIVE SYSTEM |
| Classification | Needle, Dental |
| Applicant | HEALTH TECHNOLOGY SYSTEMS, INC. 114 WOODLAND AVE. Lexington, KY 40502 |
| Contact | Henry Evans |
| Correspondent | Henry Evans HEALTH TECHNOLOGY SYSTEMS, INC. 114 WOODLAND AVE. Lexington, KY 40502 |
| Product Code | DZM |
| CFR Regulation Number | 872.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-06 |
| Decision Date | 1991-09-13 |