FDA.reportPublic FDA data

510(k) K102659

Device
MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
Applicant
Manuka Medical Limited
510(k) number
K102659
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2010-12-08
Date received
2010-09-15
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
James Smith
Address
29442 Pt.e Royale Laguna Niguel CA US 92677 92677

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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