SNAP WOUND CARE SYSTEM— 510(k) K112341

Substantially Equivalent

Spiracur, Inc.

FDA 510(k) clearance K112341 for SNAP WOUND CARE SYSTEM, Substantially Equivalent on 2011-08-29. Applicant: Spiracur, Inc.. Device class: 2.

Clearance details

Applicant: Spiracur, Inc.
Product code: Code OKO
Device class: Class 2
Regulation: 21 CFR 878.4683
Advisory panel: General, Plastic Surgery
Date received: 2011-08-15
Decision date: 2011-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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