MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES

Tube, Feeding

BENLAN, INC.

The following data is part of a premarket notification filed by Benlan, Inc. with the FDA for Med-rx Pediatric Feeding Tubes And Accessories.

Pre-market Notification Details

Device IDK100700
510k NumberK100700
Device Name:MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
ClassificationTube, Feeding
Applicant BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario,  CA L6h 5t4
ContactCheryl Brown
CorrespondentCheryl Brown
BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario,  CA L6h 5t4
Product CodeFPD  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-12
Decision Date2010-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628725004617 K100700 000
00628725002927 K100700 000
00628725002910 K100700 000
00628725002903 K100700 000
00628725002897 K100700 000
00628725002880 K100700 000
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00628725002859 K100700 000
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50628725003868 K100700 000
50628725003912 K100700 000
00628725003672 K100700 000
00628725002934 K100700 000
00628725002941 K100700 000
00628725003887 K100700 000
00628725003870 K100700 000
00628725003818 K100700 000
00628725003030 K100700 000
00628725003023 K100700 000
00628725003016 K100700 000
00628725003009 K100700 000
00628725002996 K100700 000
00628725002989 K100700 000
00628725002972 K100700 000
00628725002965 K100700 000
00628725002958 K100700 000
50628725004322 K100700 000

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