IOVERA
Device, Surgical, Cryogenic
MYOSCIENCE INC
The following data is part of a premarket notification filed by Myoscience Inc with the FDA for Iovera.
Pre-market Notification Details
| Device ID | K133453 |
| 510k Number | K133453 |
| Device Name: | IOVERA |
| Classification | Device, Surgical, Cryogenic |
| Applicant | MYOSCIENCE INC 1600 SEAPORT BLVD, STE 450 NORTH LOBBY Redwood City, CA 94063 |
| Contact | Bijesh Chandran |
| Correspondent | Bijesh Chandran 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 | 2013-11-12 |
| Decision Date | 2014-03-24 |
| Summary: | summary |
Trademark Results [IOVERA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IOVERA 85410565 4377036 Live/Registered |
PACIRA CRYOTECH, INC. 2011-08-30 |
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