The following data is part of a premarket notification filed by Amsino Intl., Inc. with the FDA for Amsino Cervical Scraper.
| Device ID | K950780 |
| 510k Number | K950780 |
| Device Name: | AMSINO CERVICAL SCRAPER |
| Classification | Spatula, Cervical, Cytological |
| Applicant | AMSINO INTL., INC. 222 SOUTH FIFTH AVE. City Of Industry, CA 91746 -2900 |
| Contact | Richard Y Li |
| Correspondent | Richard Y Li AMSINO INTL., INC. 222 SOUTH FIFTH AVE. City Of Industry, CA 91746 -2900 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811382011085 | K950780 | 000 |