MACROPOREDX DISTRACTOR SYSTEM

External Mandibular Fixator And/or Distractor

MACROPORE BIOSURGERY, INC.

The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macroporedx Distractor System.

Pre-market Notification Details

Device IDK000992
510k NumberK000992
Device Name:MACROPOREDX DISTRACTOR SYSTEM
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
ContactKenneth K Kleinhenz
CorrespondentKenneth K Kleinhenz
MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-28
Decision Date2000-06-26

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