EASY TOUCH

Needle, Hypodermic, Single Lumen

MHC MEDICAL PRODUCTS, LLC

The following data is part of a premarket notification filed by Mhc Medical Products, Llc with the FDA for Easy Touch.

Pre-market Notification Details

• Device ID: K112789
• 510k Number: K112789
• Device Name: EASY TOUCH
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: MHC MEDICAL PRODUCTS, LLC 8870 RAVELLO CT. Naples, FL 34114
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; MHC MEDICAL PRODUCTS, LLC 8870 RAVELLO CT. Naples, FL 34114
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-26
• Decision Date: 2011-12-23
• Summary: summary