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510(k) K935763

Device
SURGIPUMP
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
510(k) number
K935763
Product code
DQI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-21
Date received
1993-11-26
Regulation
870.1800
Classification name
Withdrawal/infusion Pump
Medical specialty
Cardiovascular
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
OWEN B LAMB
Address
C/O Qualitivity 8536 Calle Tioga Tucson AZ US 85704 85704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K871422OLYMPUS ANGIOSCOPY PUMPOlympus Corp.1987-08-12

Legacy Summary#

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FDA Review#

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