SPINAL FORAMINOSCOPE

Arthroscope

BLAZEJEWSKI MEDI-TECH GMBH

The following data is part of a premarket notification filed by Blazejewski Medi-tech Gmbh with the FDA for Spinal Foraminoscope.

Pre-market Notification Details

Device IDK082841
510k NumberK082841
Device Name:SPINAL FORAMINOSCOPE
ClassificationArthroscope
Applicant BLAZEJEWSKI MEDI-TECH GMBH AMSTEL 320-I Amsterdam,  NL 1017ap
ContactAngelika Scherp
CorrespondentAngelika Scherp
BLAZEJEWSKI MEDI-TECH GMBH AMSTEL 320-I Amsterdam,  NL 1017ap
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-26
Decision Date2009-09-09
Summary:summary

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