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510(k) K913678

Device
TROCAR CATHETER
Applicant
MEDOVATIONS, INC.
510(k) number
K913678
Product code
KGY  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-16
Date received
1991-08-19
Regulation
878.4100
Classification name
Bag, Intestine
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRIAN E LARSON
Address
102 E. Keefe Ave. Milwaukee WI US 53212 53212

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933085GOODMAN BANDAGEMegadyne Medical Products, Inc.1993-12-23
K910914SURGICAL TISSUE POUCHCook Urological, Inc.1991-03-28
K832318ISOLATION BAG 3M3M Company1983-10-31
K801823BAND-AID BRAND TRICOT MESH BANDAGESJohnson & Johnson Professionals, Inc.1980-08-20
K801824BAND-AID BRAND FLEXIBLE FABRIC BANDAGEJohnson & Johnson Professionals, Inc.1980-08-20

Legacy Summary#

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FDA Review#

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