VAN DELLEN HEALON CANNULA

Cannula, Ophthalmic

VAN DELLEN, LTD.

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

Pre-market Notification Details

Device IDK873164
510k NumberK873164
Device Name:VAN DELLEN HEALON CANNULA
ClassificationCannula, Ophthalmic
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 CodeHMX  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-11
Decision Date1987-09-04

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