The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Elec-mate, Models Ex-6 Set, Ex-6l Set, Ex-30 Set.
| Device ID | K990954 |
| 510k Number | K990954 |
| Device Name: | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Contact | Hiroshi Sekiguchi |
| Correspondent | Hiroshi Sekiguchi NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-22 |
| Decision Date | 1999-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10194665005467 | K990954 | 000 |