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510(k) K961287

Device
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
Applicant
ROCKET MEDICAL PLC
510(k) number
K961287
Product code
KDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-26
Date received
1996-04-03
Regulation
880.6740
Classification name
Bottle, Collection, Vacuum
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
L TODD
Address
Factories 3 & 4, Wear Industrial Estate Washington, Tyne & Wear GB NE37 1NE NE37 1NE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K892915PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTIONDeknatel, Inc.1989-06-21

Legacy Summary#

summary

FDA Review#

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