Cleared Traditional

SURGICAL DYNAMICS DISCOGRAPHY SYSTEM

K921950 · Surgical Dynamics, Inc. · General Hospital
Jun 1993
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K921950 is an FDA 510(k) clearance for the SURGICAL DYNAMICS DISCOGRAPHY SYSTEM, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Surgical Dynamics, Inc. (Alameda, US). The FDA issued a Cleared decision on June 7, 1993, 406 days after receiving the submission on April 27, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K921950 FDA.gov
FDA Decision Cleared SEKD
Date Received April 27, 1992
Decision Date June 07, 1993
Days to Decision 406 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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