HISTOFREEZER DEVICE

Unit, Cryosurgical, Accessories

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Histofreezer Device.

Pre-market Notification Details

Device IDK982358
510k NumberK982358
Device Name:HISTOFREEZER DEVICE
ClassificationUnit, Cryosurgical, Accessories
Applicant ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem,  PA  18018 -1799
ContactR.sam Niedbala
CorrespondentR.sam Niedbala
ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem,  PA  18018 -1799
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-06
Decision Date1998-10-02

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