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510(k) K911813

Device
ENTREE CANNULA
Applicant
CORE DYNAMICS, INC.
510(k) number
K911813
Product code
FBM  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-19
Date received
1991-04-23
Regulation
876.5090
Classification name
Cannula And Trocar, Suprapubic, Non-disposable
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TIM REIS
Address
11222-4 St. Johns Industrial Pkwy. Jacksonville FL US 32246 32246

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FBM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960400DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)Snowden-Pencer1996-03-12
K932021ENTREE CANNULA FASCIA ANCHORSCore Dynamics, Inc.1994-01-11
K900955GS-4000 REDUCER SLEEVE, 11MM TO 5MMSolos Endoscopy, Inc.1990-04-18
K900961GS-4100 REDUCER SLEEVE, 5MM TO 3MMSolos Endoscopy, Inc.1990-04-18
K900962GS-4300 CANNULA AND TROCAR, 5.5MMSolos Endoscopy, Inc.1990-04-18
K900963GS-4350 TROCAR ONLY, 5.5MMSolos Endoscopy, Inc.1990-04-18
K900964CANNULA AND TROCAR, 11MMSolos Endoscopy, Inc.1990-04-18
K900965GS-4550 TROCAR ONLY, 11MMSolos Endoscopy, Inc.1990-04-18

Legacy Summary#

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FDA Review#

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