OSTEOMED INTRAORAL DISTRACTION SYSTEM

External Mandibular Fixator And/or Distractor

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Intraoral Distraction System.

Pre-market Notification Details

Device IDK990944
510k NumberK990944
Device Name:OSTEOMED INTRAORAL DISTRACTION SYSTEM
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant OSTEOMED CORP. 3750 REALTY RD. Addison,  TX  75001 -4311
ContactRick A Buss
CorrespondentRick A Buss
OSTEOMED CORP. 3750 REALTY RD. Addison,  TX  75001 -4311
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-22
Decision Date1999-06-16
Summary:summary

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