The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Surgical Angle Handpiece, Surgical Straight Handpiece.
| Device ID | K171155 |
| 510k Number | K171155 |
| Device Name: | Surgical Angle Handpiece, Surgical Straight Handpiece |
| Classification | Handpiece, Rotary Bone Cutting |
| Applicant | Nakanishi Inc. 700 Shimonhinata Kanuma-shi, JP 322-8666 |
| Contact | Kimihiko Satoh |
| Correspondent | Belia Juarez Ken Block Consulting 1201 Richardson Dr. Richardson, TX 75080 |
| Product Code | KMW |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264556294 | K171155 | 000 |
| 04560264556287 | K171155 | 000 |
| 04560264556270 | K171155 | 000 |
| 04560264556263 | K171155 | 000 |