Pump, Portable, Aspiration (manual Or Powered)

DRW Medical

The following data is part of a premarket notification filed by Drw Medical with the FDA for Exsalta.

Pre-market Notification Details

Device IDK221676
510k NumberK221676
Device Name:Exsalta
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant DRW Medical 2710 Concord Road Aston,  PA  19104
ContactDan Tatum
CorrespondentPaul Dryden
ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg,  FL  33704
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-09
Decision Date2022-09-16

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