Product code HNW— Ophthalmic

FDA has cleared 3 devices under product code HNW between 1981 and 1986, 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.

• 19861 clearance
• 19841 clearance
• 19811 clearance

• Premier Dental Products Co.1 clearance
• Koi, Inc.1 clearance
• Intermedics Intraocular, Inc.1 clearance

• K862070 — INTER-SHARPIntermedics Intraocular, Inc.·1986-06-17
• K841002 — LACHRYMAL PROBES-VARIOUSPremier Dental Products Co.·1984-05-09
• K812097 — KOI LACREMAL HOOK & DILATORKoi, Inc.·1981-08-18