510(k) K843282

UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC by Rush Hampton Industries — Product Code BWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1984
Date Received
August 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Bronchoscope (Non-Rigid)
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).