The following data is part of a premarket notification filed by Myoscience Inc with the FDA for Cryo-touch Iv.
| Device ID | K123516 |
| 510k Number | K123516 |
| Device Name: | CRYO-TOUCH IV |
| Classification | Device, Surgical, Cryogenic |
| Applicant | MYOSCIENCE INC 1600 SEAPORT BLVD, STE 450 NORTH LOBBY Redwood City, CA 94063 |
| Contact | Tracey Henry |
| Correspondent | Tracey Henry MYOSCIENCE INC 1600 SEAPORT BLVD, STE 450 NORTH LOBBY Redwood City, CA 94063 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-14 |
| Decision Date | 2013-01-10 |
| Summary: | summary |