Product code LRD— Ear, Nose, Throat

FDA has cleared 6 devices under product code LRD between 1992 and 1999, filed by 6 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.

• 19991 clearance
• 19943 clearances
• 19931 clearance
• 19921 clearance

• The Merlin Corp.1 clearance
• Hospitak, Inc.1 clearance
• Envis, Inc.1 clearance
• Denver Splint Co.1 clearance
• Customed, Inc.1 clearance
• Amsco Sterile Recoveries, Inc.1 clearance

• K984345 — AROMAPATCHEnvis, Inc.·1999-03-19
• K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKSAmsco Sterile Recoveries, Inc.·1994-09-09
• K942789 — MISTASSISTThe Merlin Corp.·1994-08-12
• K940133 — THE EXPANDACELL EAR PACKDenver Splint Co.·1994-05-23
• K925022 — SURGICAL TRAY (STERILE)Customed, Inc.·1993-04-26
• K920842 — AEROSOL DELIVERY SYSTEMSHospitak, Inc.·1992-05-15