Cleared Traditional

MIC-100 WITH CRYOPROBES

K891282 · Frigitronics of Connecticut, Inc. · General & Plastic Surgery
Jun 1989
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K891282 is an FDA 510(k) clearance for the MIC-100 WITH CRYOPROBES, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Frigitronics of Connecticut, Inc. (Shelton, US). The FDA issued a Cleared decision on June 15, 1989, 98 days after receiving the submission on March 9, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K891282 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1989
Decision Date June 15, 1989
Days to Decision 98 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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