SCANLAN VASCU-STATT

Protector, Skin Pressure

SCANLAN INTL., INC.

The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan Vascu-statt.

Pre-market Notification Details

Device IDK802829
510k NumberK802829
Device Name:SCANLAN VASCU-STATT
ClassificationProtector, Skin Pressure
Applicant SCANLAN INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMP  
CFR Regulation Number880.6450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-10
Decision Date1981-01-15

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