VAN DELLEN RETROBULBAR NEEDLE

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 Retrobulbar Needle.

Pre-market Notification Details

Device IDK873162
510k NumberK873162
Device Name:VAN DELLEN RETROBULBAR NEEDLE
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

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