Cleared Traditional

ORTHOVISION TABLE

K905816 · American Sterilizer Co. · General & Plastic Surgery
Mar 1991
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K905816 is an FDA 510(k) clearance for the ORTHOVISION TABLE, a Table, Surgical With Orthopedic Accessories, Manual (Class I — General Controls, product code JEB), submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on March 6, 1991, 68 days after receiving the submission on December 28, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K905816 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1990
Decision Date March 06, 1991
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code JEB — Table, Surgical With Orthopedic Accessories, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4950

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