Cleared Traditional

HISTOFREEZER

K931299 · Solarcare Technologies Corp,Inc. · General & Plastic Surgery
Aug 1993
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K931299 is an FDA 510(k) clearance for the HISTOFREEZER, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 11, 1993, 149 days after receiving the submission on March 15, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K931299 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1993
Decision Date August 11, 1993
Days to Decision 149 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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