Avulsion Forceps

Forceps, Biopsy, Electric

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Avulsion Forceps.

Pre-market Notification Details

Device IDK183428
510k NumberK183428
Device Name:Avulsion Forceps
ClassificationForceps, Biopsy, Electric
Applicant STERIS Corporation 5976 Heisley Rd Mentor,  OH  44060
ContactEileen Mccafferty
CorrespondentEileen Mccafferty
STERIS Corporation 5976 Heisley Rd Mentor,  OH  44060
Product CodeKGE  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-11
Decision Date2019-04-16

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