The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Portable Electric Motor-handpiece Unit, Handy-mate.
| Device ID | K990646 |
| 510k Number | K990646 |
| Device Name: | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264572638 | K990646 | 000 |
| 04560264502222 | K990646 | 000 |
| 04560224971600 | K990646 | 000 |
| 04560264540422 | K990646 | 000 |
| 04560224971617 | K990646 | 000 |