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510(k) K942544

Device
GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS
Applicant
MEDI-GLOBE CORP.
510(k) number
K942544
Product code
LQC  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-22
Date received
1994-05-31
Regulation
876.4500
Classification name
Lithotriptor, Biliary Mechanical
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GINA M GALLEGOS
Address
6202 S. Maple Ave. # 131 Tempe AZ US 85283 85283

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040447TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088Boston Scientific Corp2004-03-12
K011178WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTORWilson-Cook Medical, Inc.2001-05-04
K964937A LITHOTRIPTER-COMPATIBLE BASKETBoston Scientific Corp1997-01-24
K943191MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTORBoston Scientific Corp1994-08-29
K905552LAPAROLITHBaxter Healthcare Corp1991-12-17
K911364SPOON FORCEPS, 11MMNorthgate Technologies, Inc.1991-10-23
K911477LAPAROSCOPIC BASKET FLEXIBLE AND RIGIDUnited States Endoscopy Group, Inc.1991-08-14
K903529BML SERIESOlympus Corp.1991-01-23
K902170SOEHENDRA LITHOTRIPSY SETWilson-Cook Medical, Inc.1990-07-25
K860863ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHERGeorge Percy Mcgown1986-05-15

Legacy Summary#

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FDA Review#

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