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510(k) K003965

Device
MRI SAFE INSTRUMENTS
Applicant
AESCULAP, INC.
510(k) number
K003965
Product code
GEA  
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-16
Date received
2000-12-22
Regulation
878.4800
Classification name
Cannula, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LISA M MILLINGTON
Address
944 Marcon Blvd. Allentown PA US 18109 18109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GEA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K982472GENICON TROCARGenicon, LC1999-02-04
K954599CONMED TROGARD ELECTRONIC TROCAR SYSTEMConmedcorp1995-11-27
K922460ORIGIN SECONDARY CANNULA AND TROCAROrigin Medsystems, Inc.1992-09-16
K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEETHICON, Inc.1992-04-02
K911262DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCERETHICON, Inc.1991-06-20
K904881DISPOSABLE YANKAUER SUCTION TUBEPilling Medical S.A.1991-03-06
K903416CANNULA, SURGICALAdvantage Diagnostics Corp.1990-11-23
K904218SUCTION SYSTEMAxiom Medical, Inc.1990-10-31
K901717KLEIN MICRO-CANNULA(TM)Jeff Klein Surgical, Inc.1990-05-24
K901718KLEIN LAMPREY-CANNULA(TM)Jeff Klein Surgical, Inc.1990-05-24
K901719KLEIN MICRO-CANNULA HANDLE(TM)Jeff Klein Surgical, Inc.1990-05-22
K895684SOFT SUCTION ADAPTERApplied Medical Technologies1989-11-20
K896434AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*United States Surgical, A Division of Tyco Healthc1989-11-16
K895762CANULA SUCTION FOR SURGICAL GENERAL AND PLASTICKolster Methods1989-10-18
K895670SURGICAL SUCTION APPARATUSBaker-Sundt Research, Inc.1989-09-27

Legacy Summary#

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FDA Review#

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