SPECIMEN COLLECTION DEVICE

Container, Specimen, Sterile

UROL, INC.

The following data is part of a premarket notification filed by Urol, Inc. with the FDA for Specimen Collection Device.

Pre-market Notification Details

Device IDK780049
510k NumberK780049
Device Name:SPECIMEN COLLECTION DEVICE
ClassificationContainer, Specimen, Sterile
Applicant UROL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMH  
CFR Regulation Number864.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-01-09
Decision Date1978-01-26

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