FDA.report

510(k) K910377

Device
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
Applicant
COOPERSURGICAL, INC.
510(k) number
K910377
Product code
GCX  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-19
Date received
1991-01-29
Regulation
880.6740
Classification name
Apparatus, Suction, Operating-room, Wall Vacuum Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CHARLES L ROSE
Address
C/O Charles I. Rose & Co, Inc. 1963 Rock St., Suite #17 Mountain View CA US 94043 94043

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00888937026597LEEP PRECISION™ Smoke EvacuatorCoopersurgical, Inc.2024-06-17
00888937019940LEEP PRECISION™ Smoke Evacuation SystemCoopersurgical, Inc.2017-09-27
00888937014440LEEP System 1000® Smoke Evacuation SystemCoopersurgical, Inc.2016-09-22
00888937014327LEEP PRECISION™ Smoke EvacuationCoopersurgical, Inc.2016-09-22
00888937014242LEEP PRECISION™ Smoke Evacuation SystemCoopersurgical, Inc.2016-09-22
20888937000058Smoke Evacuator TubingCoopersurgical, Inc.2016-02-02

Legacy Summary

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FDA Review

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