VERSCHLUBSTOPFEN COMB-CLOSING STOPPER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

BURRON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Verschlubstopfen Comb-closing Stopper.

Pre-market Notification Details

Device IDK813396
510k NumberK813396
Device Name:VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-04
Decision Date1982-01-12

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