SURGICOUNT SAFETY-SPONGE SYSTEM

Counter, Sponge, Surgical

SURGICOUNT MEDICAL

The following data is part of a premarket notification filed by Surgicount Medical with the FDA for Surgicount Safety-sponge System.

Pre-market Notification Details

Device IDK060076
510k NumberK060076
Device Name:SURGICOUNT SAFETY-SPONGE SYSTEM
ClassificationCounter, Sponge, Surgical
Applicant SURGICOUNT MEDICAL 5582 CHALON ROAD Yorba Linda,  CA  92886
ContactSharon Rockwell
CorrespondentSharon Rockwell
SURGICOUNT MEDICAL 5582 CHALON ROAD Yorba Linda,  CA  92886
Product CodeLWH  
CFR Regulation Number880.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-10
Decision Date2006-03-14
Summary:summary

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