Product code HBN— Neurology

FDA has cleared 4 devices under product code HBN between 1982 and 1990, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19901 clearance
• 19823 clearances

• Surgi-Quip Inc.U2 clearances
• Skytron, Div. the Kmw Group, Inc.1 clearance
• Kelleher Corp.1 clearance

• K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUISkytron, Div. the Kmw Group, Inc.·1990-09-04
• K822426 — MCINTYRE MICROSCOPE STANDSurgi-Quip Inc.U·1982-09-02
• K822428 — SURGI-QUIP MICROSCOPE STANDSurgi-Quip Inc.U·1982-09-02
• K822012 — BINOCULAR OPERATING MICROSCOPES &Kelleher Corp.·1982-07-30