UNIDRIVE II PLUS DISPOSABLE TUBING SET

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

MTP MEDICAL TECHNICAL PROMOTION GMBH

The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Unidrive Ii Plus Disposable Tubing Set.

Pre-market Notification Details

Device IDK021811
510k NumberK021811
Device Name:UNIDRIVE II PLUS DISPOSABLE TUBING SET
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City,  CA  90230
ContactJames A Lee
CorrespondentJames A Lee
MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City,  CA  90230
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-03
Decision Date2002-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048438001042 K021811 000

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