ATRAUMATIC SPECIAL SPROTTE NEEDLE

Needle, Conduction, Anesthetic (w/wo Introducer)

PAJUNK GMBH

The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Atraumatic Special Sprotte Needle.

Pre-market Notification Details

Device IDK911221
510k NumberK911221
Device Name:ATRAUMATIC SPECIAL SPROTTE NEEDLE
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant PAJUNK GMBH WASHINGTON SQUARE SUITE 1100 1050 CONNECTICUT AVENUE N.W. Washington,  DC  20036
ContactBruce Mackler
CorrespondentBruce Mackler
PAJUNK GMBH WASHINGTON SQUARE SUITE 1100 1050 CONNECTICUT AVENUE N.W. Washington,  DC  20036
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-19
Decision Date1992-07-24

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