Product code LRQ— Unknown

“This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

FDA has cleared 6 devices under product code LRQ between 1986 and 1996, 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.

• 19962 clearances
• 19952 clearances
• 19871 clearance
• 19861 clearance

• Welmed Systems, Inc.1 clearance
• Premium Plastics, Inc.1 clearance
• Medcare Medical Group, Inc.1 clearance
• Grand Medical Products1 clearance
• Contour Fabricators of Florida, Inc.1 clearance
• Automatic Liquid Packaging, Inc.1 clearance

• K963720 — TRACHEOSTOMY KITGrand Medical Products·1996-11-27
• K961167 — MEDCARE TRACHEOSTOMY CARE TRAYMedcare Medical Group, Inc.·1996-07-02
• K952925 — READY NURSE SYSTEM (RNS) TRACH CARE KITContour Fabricators of Florida, Inc.·1995-07-12
• K950851 — GENT-L-KARE TRACHEOSTOMY TRAYSPremium Plastics, Inc.·1995-06-21
• K871692 — TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1Automatic Liquid Packaging, Inc.·1987-06-01
• K862663 — TRACHEOSTOMY CARE TRAYWelmed Systems, Inc.·1986-07-30