The following data is part of a premarket notification filed by Anderson Winn Paper Co. with the FDA for Cytex One And Cytex Two.
| Device ID | K890283 |
| 510k Number | K890283 |
| Device Name: | CYTEX ONE AND CYTEX TWO |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ANDERSON WINN PAPER CO. 1101 W. CHESTNUT ST. Burbank, CA 91506 |
| Contact | Abner Levy |
| Correspondent | Abner Levy ANDERSON WINN PAPER CO. 1101 W. CHESTNUT ST. Burbank, CA 91506 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-19 |
| Decision Date | 1989-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10187207000204 | K890283 | 000 |
| 20187207000089 | K890283 | 000 |
| 20187207000096 | K890283 | 000 |
| 20187207000102 | K890283 | 000 |
| 20187207000126 | K890283 | 000 |
| 20187207000133 | K890283 | 000 |
| 20187207000140 | K890283 | 000 |
| 20187207000157 | K890283 | 000 |
| 20187207000164 | K890283 | 000 |
| 20187207000171 | K890283 | 000 |
| 20187207000188 | K890283 | 000 |
| 20187207000195 | K890283 | 000 |
| 00187207000078 | K890283 | 000 |