EXCEL INFLATE-AID

Injector And Syringe, Angiographic

MEDICAL PROFILES, INC.

The following data is part of a premarket notification filed by Medical Profiles, Inc. with the FDA for Excel Inflate-aid.

Pre-market Notification Details

Device IDK883769
510k NumberK883769
Device Name:EXCEL INFLATE-AID
ClassificationInjector And Syringe, Angiographic
Applicant MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia,  MI  48150
ContactBone, Ii
CorrespondentBone, Ii
MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia,  MI  48150
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-06
Decision Date1988-12-01

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