The following data is part of a premarket notification filed by Kolplast Ci Sa with the FDA for Kolplast Cervical Sample Collection Kit.
| Device ID | K153128 |
| 510k Number | K153128 |
| Device Name: | Kolplast Cervical Sample Collection Kit |
| Classification | Spatula, Cervical, Cytological |
| Applicant | KOLPLAST CI SA ESTRADA MUNICIPAL IVA 136. NO 418. BARRIO DA MINA Itupeva- Sp, BR 13295-000 |
| Contact | Daniela Feracin |
| Correspondent | Yolanda Smith Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-29 |
| Decision Date | 2017-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898027905902 | K153128 | 000 |
| 07898027908460 | K153128 | 000 |