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K Number
K002315
Device Name
WISEBANDS SKIN CLOSURE DEVICE
Manufacturer
WISEBANDS LTD.
Date Cleared
2001-03-15

(227 days)

Product Code
MKY
Regulation Number
878.4320
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 878.4320 Removable skin clip.

(a)
Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.