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510(k) K882223

Device
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
Applicant
DEKNATEL, INC.
510(k) number
K882223
Product code
KDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-16
Date received
1988-05-26
Regulation
880.6740
Classification name
Bottle, Collection, Vacuum
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BETTY OROFINO
Address
2300 Marcus Ave. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081718EXPRESS CHEST DRAINAtrium Medical Corp.2008-07-25
K062302MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEMMillicore AB2006-10-06
K043582OCEAN CHEST DRAINAtrium Medical Corp.2005-01-21
K984496ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAINAtrium Medical Corp.1999-05-05
K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRDeknatel, Inc.1996-08-28
K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEMRocket Medical Plc1996-07-26
K962168MUCUS SPECIMEN TRAPSage Products, Inc.1996-07-22
K950677ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAINAtrium Medical Corp.1995-04-13
K941818PM9000 VAC TRAPPrecision Medical, Inc.1994-12-12
K932327THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEMDavol, Inc.1993-07-13
K912704ATRIUM 2000 CHEST DRAINAtrium Medical Corp.1991-08-26
K905768PLEUR-EVAC CHEST DRAINAGE SYSTEMSDeknatel, Inc.1991-02-11
K897125ATRIUM 2000, CHEST DRAINAtrium Medical Corp.1990-03-30
K896697PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAIDeknatel, Inc.1990-02-08
K896127THORA-KLEX CHEST DRAINAGE UNITDavol, Inc.1990-01-24

Legacy Summary#

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FDA Review#

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