ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)

Tubes, Gastrointestinal (and Accessories)

ANDERSEN PRODUCTS, INC.

The following data is part of a premarket notification filed by Andersen Products, Inc. with the FDA for Andersen Intestinal Tube, Miller-abbott Type (an 22).

Pre-market Notification Details

Device IDK011077
510k NumberK011077
Device Name:ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant ANDERSEN PRODUCTS, INC. 3202 CAROLINE DR., HEALTH SCIENCE PARK Haw River,  NC  27258 -8710
ContactWendy Hedrick
CorrespondentWendy Hedrick
ANDERSEN PRODUCTS, INC. 3202 CAROLINE DR., HEALTH SCIENCE PARK Haw River,  NC  27258 -8710
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-09
Decision Date2001-05-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060171440581 K011077 000
05060171440574 K011077 000
05060171440567 K011077 000
05060171440550 K011077 000
05060171440543 K011077 000
05060171440536 K011077 000
05060171440352 K011077 000
05060171440345 K011077 000

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