Clearance Summary
DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET received FDA 510(k) clearance under submission number K924837, sponsored by Associated Ent., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-10-12.
- Submission: K924837
- Applicant / Sponsor: Associated Ent., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1993-10-12
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.