The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Surgic Pro, Surgic Pro+.
| Device ID | K173905 |
| 510k Number | K173905 |
| Device Name: | Surgic Pro, Surgic Pro+ |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | Nakanishi Inc. 700 Shimonhinata Kanuma-shi, JP 322-8666 |
| Contact | Kimihiko Satoh |
| Correspondent | Katie Reneson Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | EBW |
| Subsequent Product Code | EGS |
| Subsequent Product Code | KMW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913029603 | K173905 | 000 |