WISEBANDS SKIN CLOSURE DEVICE— 510(k) K002315

Substantially Equivalent

Wisebands , Ltd.

FDA 510(k) clearance K002315 for WISEBANDS SKIN CLOSURE DEVICE, Substantially Equivalent on 2001-03-15. Applicant: Wisebands , Ltd.. Device class: 1.

Clearance details

Applicant: Wisebands , Ltd.
Product code: Code MKY
Device class: Class 1
Regulation: 21 CFR 878.4320
Advisory panel: General, Plastic Surgery
Date received: 2000-07-31
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.