The following data is part of a premarket notification filed by Lares Research, Inc. with the FDA for Lares Research As-1 Lowspeed Handpiece.
| Device ID | K961163 |
| 510k Number | K961163 |
| Device Name: | LARES RESEARCH AS-1 LOWSPEED HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | LARES RESEARCH, INC. 295 LOCKHEED AVE. Chico, CA 95973 |
| Contact | Thomas H Louisell |
| Correspondent | Thomas H Louisell LARES RESEARCH, INC. 295 LOCKHEED AVE. Chico, CA 95973 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-22 |
| Decision Date | 1996-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D950114250 | K961163 | 000 |
| D95011423U0 | K961163 | 000 |
| D95011424U0 | K961163 | 000 |
| D95011425U0 | K961163 | 000 |
| D950116240 | K961163 | 000 |
| D95011624U0 | K961163 | 000 |
| D950114220 | K961163 | 000 |
| D950114230 | K961163 | 000 |
| D950114240 | K961163 | 000 |
| D95011422U0 | K961163 | 000 |