Product code HPN— Ophthalmic

FDA has cleared 5 devices under product code HPN between 1983 and 1991, filed by 5 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.

• 19911 clearance
• 19901 clearance
• 19881 clearance
• 19861 clearance
• 19831 clearance

• Richard James, Inc.1 clearance
• Miami Eye Technology, Inc.1 clearance
• King Tool, Inc.1 clearance
• Emory University School of Medicine1 clearance
• Ameritek, Inc.1 clearance

• K905237 — EYE SEE INSTRUMENTKing Tool, Inc.·1991-02-14
• K896473 — H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUREmory University School of Medicine·1990-02-09
• K880855 — PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAGRichard James, Inc.·1988-04-01
• K860960 — RARE EARTH INTRA-OCULAR MAGNETAmeritek, Inc.·1986-03-31
• K831702 — RARE-EARTH INTRA-OCULAR MAGNETMiami Eye Technology, Inc.·1983-06-30