The following data is part of a premarket notification filed by Nanning Baolai Medical Instrument Co., Ltd. with the FDA for Ultrasonic Scaler.
| Device ID | K140233 |
| 510k Number | K140233 |
| Device Name: | ULTRASONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. LEVEL 7, JIN GUI BUSINESS CENTER 982 CUNYUN RD. BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. LEVEL 7, JIN GUI BUSINESS CENTER 982 CUNYUN RD. BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970557950244 | K140233 | 000 |
| 16970557950077 | K140233 | 000 |
| 16970557950060 | K140233 | 000 |
| 16970557950053 | K140233 | 000 |
| 16970557950046 | K140233 | 000 |
| 16970557950039 | K140233 | 000 |
| 16970557950022 | K140233 | 000 |
| 16970557950015 | K140233 | 000 |
| 16970557950459 | K140233 | 000 |
| 16970557950442 | K140233 | 000 |
| 16970557950435 | K140233 | 000 |
| 16970557950428 | K140233 | 000 |
| 16970557950411 | K140233 | 000 |
| 16970557950404 | K140233 | 000 |
| 16970557950398 | K140233 | 000 |
| 16970557950084 | K140233 | 000 |
| 16970557950091 | K140233 | 000 |
| 16970557950237 | K140233 | 000 |
| 16970557950220 | K140233 | 000 |
| 16970557950213 | K140233 | 000 |
| 16970557950206 | K140233 | 000 |
| 16970557950190 | K140233 | 000 |
| 16970557950183 | K140233 | 000 |
| 16970557950176 | K140233 | 000 |
| 16970557950169 | K140233 | 000 |
| 16970557950152 | K140233 | 000 |
| 16970557950145 | K140233 | 000 |
| 16970557950138 | K140233 | 000 |
| 16970557950121 | K140233 | 000 |
| 16970557950114 | K140233 | 000 |
| 16970557950107 | K140233 | 000 |
| 06970557950469 | K140233 | 000 |