The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Surgic Ii Implant Control Unit.
| Device ID | K972924 |
| 510k Number | K972924 |
| Device Name: | SURGIC II IMPLANT CONTROL UNIT |
| Classification | Controller, Foot, Handpiece And Cord |
| 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 | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-08 |
| Decision Date | 1997-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264560055 | K972924 | 000 |
| 04560264560048 | K972924 | 000 |
| 04560264560031 | K972924 | 000 |
| 04560264530287 | K972924 | 000 |
| 04560264530270 | K972924 | 000 |
| 04560264530256 | K972924 | 000 |
| 04560264527270 | K972924 | 000 |