SNAP (R) 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 (r) Wound Care System.

Pre-market Notification Details

Device IDK111393
510k NumberK111393
Device Name:SNAP (R) WOUND CARE SYSTEM
ClassificationNegative Pressure Wound Therapy Non-powered Suction Apparatus
Applicant SPIRACUR, INC. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale,  CA  94085
ContactSarah Canio
CorrespondentSarah Canio
SPIRACUR, INC. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale,  CA  94085
Product CodeOKO  
CFR Regulation Number878.4683 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-18
Decision Date2011-07-28
Summary:summary

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