Clearance Summary
HEMASORB APPLY received FDA 510(k) clearance under submission number K121953, sponsored by Orthocon, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2012-11-21.
- Submission: K121953
- Applicant / Sponsor: Orthocon, Inc.
- Clearance pathway: Special
- Review panel: Unknown
- Device class:
- Decision date: 2012-11-21
Classification & Regulation
This clearance is catalogued under FDA product code MTJ , within the Unknown review panel as a device.