GRIP, HOSPITAL UTILITY

Device, Intravascular Catheter Securement

BAKA MANUFACTURING CO., INC.

The following data is part of a premarket notification filed by Baka Manufacturing Co., Inc. with the FDA for Grip, Hospital Utility.

Pre-market Notification Details

Device IDK781800
510k NumberK781800
Device Name:GRIP, HOSPITAL UTILITY
ClassificationDevice, Intravascular Catheter Securement
Applicant BAKA MANUFACTURING CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKMK  
CFR Regulation Number880.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-23
Decision Date1978-12-07

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