Cleared Traditional

DISPOSABLE 45 DEGREE SHAVER

K896538 · Bowen & Company, Inc. · Orthopedic

Dec 1989

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K896538 is an FDA 510(k) clearance for the DISPOSABLE 45 DEGREE SHAVER, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on December 6, 1989, 20 days after receiving the submission on November 16, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K896538 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 1989
Decision Date	December 06, 1989
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).