The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Dental Scaler And Air Polisher.
Device ID | K203615 |
510k Number | K203615 |
Device Name: | Dental Scaler And Air Polisher |
Classification | Scaler, Ultrasonic |
Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin, CN 541004 |
Contact | Yiwei Wang |
Correspondent | Sonya Lai Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN 518000 |
Product Code | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-10 |
Decision Date | 2021-12-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06944843655024 | K203615 | 000 |
06944843616872 | K203615 | 000 |
06944843655987 | K203615 | 000 |
06944843611617 | K203615 | 000 |
06944843611600 | K203615 | 000 |
06944843611594 | K203615 | 000 |
06944843611587 | K203615 | 000 |