VAN DELLEN BACTERIA FILTER

Tubing, Fluid Delivery

VAN DELLEN, LTD.

The following data is part of a premarket notification filed by Van Dellen, Ltd. with the FDA for Van Dellen Bacteria Filter.

Pre-market Notification Details

Device IDK873465
510k NumberK873465
Device Name:VAN DELLEN BACTERIA FILTER
ClassificationTubing, Fluid Delivery
Applicant VAN DELLEN, LTD. 3810 E. 44TH ST., SUITE 301 P.O. BOX 27748 Tucson,  AZ  85726
ContactRoger Danhof
CorrespondentRoger Danhof
VAN DELLEN, LTD. 3810 E. 44TH ST., SUITE 301 P.O. BOX 27748 Tucson,  AZ  85726
Product CodeFPK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-28
Decision Date1988-01-20

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