Cleared Traditional

K832816 - HALL ARTHROTOME
(FDA 510(k) Clearance)

K832816 · American Sterilizer Co. · General & Plastic Surgery device
Nov 1983
Decision
101d
Days
—
Risk

K832816 is an FDA 510(k) clearance for the HALL ARTHROTOME..

Submitted by American Sterilizer Co. (Walker, US). The FDA issued a Cleared decision on November 28, 1983, 101 days after receiving the submission on August 19, 1983.

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

Submission Details

510(k) Number K832816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date November 28, 1983
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —