The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Histofreezer Wart Removal System Or Other Proprietary Name.
| Device ID | K023487 |
| 510k Number | K023487 |
| Device Name: | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem, PA 18015 -1389 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem, PA 18015 -1389 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-17 |
| Decision Date | 2003-03-20 |
| Summary: | summary |