Cleared Traditional

GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)

K911586 · Megadyne Medical Products, Inc. · General Hospital
Jul 1991
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K911586 is an FDA 510(k) clearance for the GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC), a Tube, Aspirating, Flexible, Connecting (Class II — Special Controls, product code BYY), submitted by Megadyne Medical Products, Inc. (Murray, US). The FDA issued a Cleared decision on July 2, 1991, 84 days after receiving the submission on April 9, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K911586 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1991
Decision Date July 02, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code BYY — Tube, Aspirating, Flexible, Connecting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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