Cleared Traditional

CRYO SURG 5900

K840536 · Frigitronics of Connecticut, Inc. · General & Plastic Surgery
Apr 1984
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K840536 is an FDA 510(k) clearance for the CRYO SURG 5900, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Frigitronics of Connecticut, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1984, 75 days after receiving the submission on February 8, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K840536 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1984
Decision Date April 23, 1984
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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

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