The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Histofreezer Device.
| Device ID | K982358 |
| 510k Number | K982358 |
| Device Name: | HISTOFREEZER DEVICE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R.sam Niedbala |
| Correspondent | R.sam Niedbala ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-06 |
| Decision Date | 1998-10-02 |