VAN DELLEN ASPIRATOR

Pump, Portable, Aspiration (manual Or Powered)

VAN DELLEN, LTD.

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

Pre-market Notification Details

Device IDK873462
510k NumberK873462
Device Name:VAN DELLEN ASPIRATOR
ClassificationPump, Portable, Aspiration (manual Or Powered)
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 CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-28
Decision Date1987-09-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.