Cleared Traditional

JACKSON MULTIPURPOSE OPERATING TABLE

K910736 · Orthopedic Systems, Inc. · General & Plastic Surgery
May 1991
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K910736 is an FDA 510(k) clearance for the JACKSON MULTIPURPOSE OPERATING TABLE, a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I — General Controls, product code JEA), submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on May 21, 1991, 89 days after receiving the submission on February 21, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K910736 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1991
Decision Date May 21, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code JEA — Table, Surgical With Orthopedic Accessories, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960

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