ADAPTER FOR ELLIK EVACUATOR

Evacuator, Bladder, Manually Operated

V. MUELLER O.V. BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Adapter For Ellik Evacuator.

Pre-market Notification Details

Device IDK760793
510k NumberK760793
Device Name:ADAPTER FOR ELLIK EVACUATOR
ClassificationEvacuator, Bladder, Manually Operated
Applicant V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFFD  
CFR Regulation Number876.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-10-07
Decision Date1976-10-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.