Cleared Traditional

HISTOFREEZER DEVICE

K982358 · OraSure Technologies, Inc. · General & Plastic Surgery
Oct 1998
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K982358 is an FDA 510(k) clearance for the HISTOFREEZER DEVICE, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 2, 1998, 88 days after receiving the submission on July 6, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K982358 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1998
Decision Date October 02, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

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