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510(k) K874996

Device
PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
510(k) number
K874996
Product code
HMX  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-13
Date received
1987-12-02
Regulation
886.4350
Classification name
Cannula, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TODD J HESSEL
Address
744 Goddard Chesterfield MO US 63017 63017

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010305WEISS RETINAL CANNULAMicron Surgical, Inc.2001-05-02
K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.Com2000-05-09
K970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.1997-05-20
K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.1995-01-18
K942403INFUSION CANNULAMicrosurgical Technology, Inc.1994-08-17
K934844INTER TIP TMicrosurgical Technology, Inc.1994-04-19
K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEKirwan Surgical Products, Inc.1994-02-17
K921488ASPIRATING ENDO OCULAR PROBE W/ILLUMINATIONSurgical Technologies, Inc.1992-05-07
K915074IRRIGATOR/ASPIRATOR PROBEBiomedical Dynamics, Inc.1992-02-05
K904074VITREORETINAL INFUSION CANNULAVisitec Co.1991-02-26
K901618OCULAR INFUSION CANNULA SYSTEMTamcenan Corp.1990-05-31
K890782GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)Grieshaber & Co.1989-06-23
K882884STORZ INFUSION CANNULAStorz Instrument Co.1988-08-04
K880347ANESTHESIA/RETROBULBAR NEEDLESMyocure, Inc.1988-05-03
K875030OCU-1Rudolph Beaver, Inc.1988-05-03

Legacy Summary#

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FDA Review#

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