MANUKATEX

Dressing, Wound, Drug

MANUKA MEDICAL LIMITED

The following data is part of a premarket notification filed by Manuka Medical Limited with the FDA for Manukatex.

Pre-market Notification Details

• Device ID: K110042
• 510k Number: K110042
• Device Name: MANUKATEX
• Classification: Dressing, Wound, Drug
• Applicant: MANUKA MEDICAL LIMITED 29442 POINTE ROYALE Laguna Niguel, CA 92677
• Contact: James Smith
• Correspondent: James Smith; MANUKA MEDICAL LIMITED 29442 POINTE ROYALE Laguna Niguel, CA 92677
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2011-01-06
• Decision Date: 2011-03-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060188820512	K110042	000
05060188820451	K110042	000