Cleared Traditional

K863149 - BOWEN PROBE
(FDA 510(k) Clearance)

K863149 · Bowen & Company, Inc. · Orthopedic device

Sep 1986

Decision

21d

Days

Class 1

Risk

K863149 is an FDA 510(k) clearance for the BOWEN PROBE. This device is classified as a Probe (Class I - General Controls, product code HXB).

Submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on September 5, 1986, 21 days after receiving the submission on August 15, 1986.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K863149 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 15, 1986
Decision Date	September 05, 1986
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—