LAPAROTOMY SPONGES

Gauze/sponge, Internal, X-ray Detectable

AMERICAN HEALTHCARE CORP.

The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Laparotomy Sponges.

Pre-market Notification Details

Device IDK905135
510k NumberK905135
Device Name:LAPAROTOMY SPONGES
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant AMERICAN HEALTHCARE CORP. 30 CRAIG ST. BRANTFORD, ONTARIO N3T 5M9 Canada,  CA
ContactCarol Mason
CorrespondentCarol Mason
AMERICAN HEALTHCARE CORP. 30 CRAIG ST. BRANTFORD, ONTARIO N3T 5M9 Canada,  CA
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-15
Decision Date1991-03-06

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