The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Compound W Freeze Off Wart Removal System.
| Device ID | K060859 |
| 510k Number | K060859 |
| Device Name: | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem, PA 18015 -1389 |
| Contact | Sue Sutton-jones |
| Correspondent | Sue Sutton-jones ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem, PA 18015 -1389 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-28 |
| Decision Date | 2006-07-18 |
| Summary: | summary |