Cleared Traditional

K894336 - SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
(FDA 510(k) Clearance)

K894336 · Surgical Dynamics, Inc. · General & Plastic Surgery device
Aug 1989
Decision
21d
Days
—
Risk

K894336 is an FDA 510(k) clearance for the SURGICAL DYNAMICS DISCOGRAPHY SYSTEM..

Submitted by Surgical Dynamics, Inc. (San Leandro, US). The FDA issued a Cleared decision on August 4, 1989, 21 days after receiving the submission on July 14, 1989.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K894336 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received July 14, 1989
Decision Date August 04, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —