Clearance Summary
OBJECTS PRECISION HANDLING TEST KIT received FDA 510(k) clearance under submission number K781350, sponsored by Metro. Hospital & Health Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1978-10-17.
- Submission: K781350
- Applicant / Sponsor: Metro. Hospital & Health Center
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5370
- Decision date: 1978-10-17
Classification & Regulation
This clearance is catalogued under FDA product code ION and 21 CFR 890.5370, within the Physical Medicine review panel as a Class I device.