Cleared Traditional

LARYNGEAL SYRINGE

K822185 · Kelleher Corp. · General Hospital
Oct 1982
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K822185 is an FDA 510(k) clearance for the LARYNGEAL SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982, 87 days after receiving the submission on July 23, 1982. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K822185 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1982
Decision Date October 18, 1982
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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