Cleared Traditional

HISTOFREEZER DEVICE

K990877 · OraSure Technologies, Inc. · General & Plastic Surgery
Jun 1999
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K990877 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 June 14, 1999, 90 days after receiving the submission on March 16, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K990877 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1999
Decision Date June 14, 1999
Days to Decision 90 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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