Cleared Traditional

CRYOSEAL FS APPLICATOR SYSTEM

K071126 · Thermogenesis Corp. · General Hospital
Aug 2007
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K071126 is an FDA 510(k) clearance for the CRYOSEAL FS APPLICATOR SYSTEM, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Thermogenesis Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on August 16, 2007, 115 days after receiving the submission on April 23, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K071126 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2007
Decision Date August 16, 2007
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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