The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Sonic Scaler With Fiber Optic, Model Nas-l, Sonic Scaler Without Fiber Optic, Model Nas-nl.
| Device ID | K991021 |
| 510k Number | K991021 |
| Device Name: | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL |
| Classification | Scaler, Ultrasonic |
| 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 | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264563001 | K991021 | 000 |
| 04560264560420 | K991021 | 000 |
| 04560264560413 | K991021 | 000 |
| 04560264560406 | K991021 | 000 |
| 04560264560390 | K991021 | 000 |
| 04560264560383 | K991021 | 000 |
| 04560264560376 | K991021 | 000 |
| 04560264560147 | K991021 | 000 |
| 04560224990151 | K991021 | 000 |
| 04560224990144 | K991021 | 000 |
| 04560224990137 | K991021 | 000 |
| 04560224977527 | K991021 | 000 |
| 04560224977503 | K991021 | 000 |
| 04560224977497 | K991021 | 000 |
| 04560224977206 | K991021 | 000 |
| 04560264562141 | K991021 | 000 |
| 04560264562158 | K991021 | 000 |
| 04560264562998 | K991021 | 000 |
| 04560264562981 | K991021 | 000 |
| 04560264562974 | K991021 | 000 |
| 04560264562967 | K991021 | 000 |
| 04560264562356 | K991021 | 000 |
| 04560264562349 | K991021 | 000 |
| 04560264562233 | K991021 | 000 |
| 04560264562226 | K991021 | 000 |
| 04560264562219 | K991021 | 000 |
| 04560264562202 | K991021 | 000 |
| 04560264562196 | K991021 | 000 |
| 04560264562189 | K991021 | 000 |
| 04560264562172 | K991021 | 000 |
| 04560264562165 | K991021 | 000 |
| 04560224977190 | K991021 | 000 |