AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER

Surgical Instruments, G-u, Manual (and Accessories)

VAN-TEC, INC.

The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Al Askari Percutaneous Access Needle Holder.

Pre-market Notification Details

Device IDK851162
510k NumberK851162
Device Name:AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
ClassificationSurgical Instruments, G-u, Manual (and Accessories)
Applicant VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
ContactJames F Vance
CorrespondentJames F Vance
VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
Product CodeKOA  
CFR Regulation Number876.4730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-22
Decision Date1985-04-15

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