The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Surgic Iv Implant Control Unit.
| Device ID | K020327 |
| 510k Number | K020327 |
| Device Name: | SURGIC IV IMPLANT CONTROL UNIT |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-31 |
| Decision Date | 2002-04-08 |