The following data is part of a premarket notification filed by Ningbo Hls Medical Products Co., Ltd with the FDA for Disposable Cervical Brush.
| Device ID | K141057 |
| 510k Number | K141057 |
| Device Name: | DISPOSABLE CERVICAL BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | NINGBO HLS MEDICAL PRODUCTS CO., LTD 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu NINGBO HLS MEDICAL PRODUCTS CO., LTD 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2015-05-14 |
| Summary: | summary |