CLINITEX CAST PADDING

Component, Cast

CLINITEX MEDICAL CORP.

The following data is part of a premarket notification filed by Clinitex Medical Corp. with the FDA for Clinitex Cast Padding.

Pre-market Notification Details

Device IDK973420
510k NumberK973420
Device Name:CLINITEX CAST PADDING
ClassificationComponent, Cast
Applicant CLINITEX MEDICAL CORP. 9801 KINCEY AVE., SUITE 100 Huntersville,  NC  28078
ContactHowell H Michael
CorrespondentHowell H Michael
CLINITEX MEDICAL CORP. 9801 KINCEY AVE., SUITE 100 Huntersville,  NC  28078
Product CodeLGF  
CFR Regulation Number888.5940 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-10
Decision Date1997-12-09

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