INTEGRA IMMOBILIZATION SYSTEM

Accelerator, Linear, Medical

DIACOR, INC.

The following data is part of a premarket notification filed by Diacor, Inc. with the FDA for Integra Immobilization System.

Pre-market Notification Details

Device IDK050888
510k NumberK050888
Device Name:INTEGRA IMMOBILIZATION SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City,  UT  84109
ContactGlenn N Waterman
CorrespondentGlenn N Waterman
DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City,  UT  84109
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-07
Decision Date2005-05-23
Summary:summary

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