STERILE PROTECTIVE SLEEVE W/TOUGH-BORST

Catheter, Intravascular, Diagnostic

UNIVERSAL MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Sterile Protective Sleeve W/tough-borst.

Pre-market Notification Details

Device IDK822290
510k NumberK822290
Device Name:STERILE PROTECTIVE SLEEVE W/TOUGH-BORST
ClassificationCatheter, Intravascular, Diagnostic
Applicant UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-02
Decision Date1982-08-31

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