510(k) K223098 · OQY Intrauterine Tamponade Balloon

Bakri Essential Postpartum Balloon

Applicant	Cook Incorporated, Bloomington IN, US
Decision	Substantially Equivalent, Oct 28, 2022
Received	Sep 30, 2022
Type	Special
FDA record	Open on fda.gov

Recalls that name K223098

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.