The following data is part of a premarket notification filed by Myoscience Inc with the FDA for Myoscience Cryo-touch.
| Device ID | K083493 |
| 510k Number | K083493 |
| Device Name: | MYOSCIENCE CRYO-TOUCH |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | MYOSCIENCE INC 525 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Tracey Henry |
| Correspondent | Tracey Henry MYOSCIENCE INC 525 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-03-20 |
| Summary: | summary |