SNaP Wound Care System

Negative Pressure Wound Therapy Non-powered Suction Apparatus

SPIRACUR, INC.

The following data is part of a premarket notification filed by Spiracur, Inc. with the FDA for Snap Wound Care System.

Pre-market Notification Details

Device IDK151710
510k NumberK151710
Device Name:SNaP Wound Care System
ClassificationNegative Pressure Wound Therapy Non-powered Suction Apparatus
Applicant SPIRACUR, INC. 1180 BORDEAUX DRIVE Sunnyvale,  CA  94089
ContactLawrence Hu
CorrespondentRonald S. Warren
EXPERIEN GROUP, LLC 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale,  CA  94085
Product CodeOKO  
CFR Regulation Number878.4683 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-24
Decision Date2015-11-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.