Cleared Traditional

HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS

K980739 · OraSure Technologies, Inc. · General & Plastic Surgery
May 1998
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K980739 is an FDA 510(k) clearance for the HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS, 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 May 26, 1998, 90 days after receiving the submission on February 25, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K980739 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1998
Decision Date May 26, 1998
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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