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510(k) K871422

Device
OLYMPUS ANGIOSCOPY PUMP
Applicant
OLYMPUS CORP.
510(k) number
K871422
Product code
DQI  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-12
Date received
1987-04-09
Regulation
870.1800
Classification name
Withdrawal/infusion Pump
Medical specialty
Cardiovascular
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WAYNE LIPSON
Address
4 Nevada Dr. 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 DQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960486KSEA MODEL 383320 20 ANGIOMATKarl Storz Endoscopy1996-10-25
K935763SURGIPUMPW.O.M. World of Medicine GmbH1994-04-21
K922541USCI SUPER 9 PTCA GUIDING CATHETERC.R. Bard, Inc.1992-12-08
K924110LEOCOR CORFLO PUMP -- MODIFICATIONLeocor, Inc.1992-09-01
K905189BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)Baxter Healthcare Corp1991-01-30
K902444CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMPIntramed Laboratories, Inc.1990-08-30
K895688NOBLES-LAI ENGINEERING INFUSION PUMPNobles-Lai Engineering, Inc.1990-02-26
K895074ANGIOSCOPY PUMPBaxter Healthcare Corp1990-01-31

Legacy Summary#

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FDA Review#

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