PosiSep ME Fragmentable Ear Dressing

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Hemostasis LLC

The following data is part of a premarket notification filed by Hemostasis Llc with the FDA for Posisep Me Fragmentable Ear Dressing.

Pre-market Notification Details

Device IDK210411
510k NumberK210411
Device Name:PosiSep ME Fragmentable Ear Dressing
ClassificationPolymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant Hemostasis LLC 5000 Township Pkwy St Paul,  MN  55110
ContactLakshmi Ganesh Bollina
CorrespondentLakshmi Ganesh Bollina
Hemostasis LLC 5000 Township Pkwy St Paul,  MN  55110
Product CodeNHB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-11
Decision Date2022-05-05

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