The following data is part of a premarket notification filed by Birchwood Laboratories, Inc. with the FDA for Cytoset(tm).
| Device ID | K902589 |
| 510k Number | K902589 |
| Device Name: | CYTOSET(TM) |
| Classification | Spatula, Cervical, Cytological |
| Applicant | BIRCHWOOD LABORATORIES, INC. 7900 FULLER RD. Eden Prairie, MN 55344 -2195 |
| Contact | Michael D Lenarz |
| Correspondent | Michael D Lenarz BIRCHWOOD LABORATORIES, INC. 7900 FULLER RD. Eden Prairie, MN 55344 -2195 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-09-10 |