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510(k) K980915

Device
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
Applicant
VALLEYLAB, INC.
510(k) number
K980915
Product code
FYD  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-29
Date received
1998-03-11
Regulation
878.5070
Classification name
Apparatus, Exhaust, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARLES M COPPERBERG
Address
5920 Longbow Dr. P.O. Box 9015 Boulder CO US 80301 80301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FYD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240127PlumeSafe X5 Smoke Management SystemConmed Corporation2024-08-05
K2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation2024-04-10
K213068Medline Smoke Evacuation ShroudMedline Industries, Inc.2022-01-03
K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.2021-03-25
K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.2020-06-26
K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.2019-08-29
K191328Megadyne Foot SwitchMegadyne Medical Products, Inc.2019-07-26
K182224SafeAir Smoke Evacuator compactLina Medical Aps2019-02-07
K173108SmokleanSejong Medical Co., Ltd.2018-05-18
K163659Crystal VisionI.C Medical, Inc.2017-10-30
K142335RapidVac Smoke Evacuator SystemCovidien2015-01-14
K131402VISICLEAR SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.2014-03-03
K091139CONMED AER DEFENSE SMOKE EVACUATORConmed Corporation2009-05-05
K053464SERVICE MANAGER SM40SEConmed Integrated Systems, Canada, Ulc2006-06-06
K052797LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUMMedtek Devices, Inc.2006-02-13

Legacy Summary#

summary

FDA Review#

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