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510(k) K971354

Device
KNOTT NG TUBE
Applicant
MICHAEL M. KNOTT, M.D.
510(k) number
K971354
Product code
FEG  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-19
Date received
1997-04-11
Regulation
876.5980
Classification name
Tube, Double Lumen For Intestinal Decompression And/or Intubation
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
MICHAEL M KNOTT
Address
355 Pine Rose Ct. Tahoe City CA US 96145 96145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd.2017-08-01
K132314MEDLINE ANTI-REFLUX VALVEMedline Industries, Inc.2013-09-18
K053410GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTORKendall2006-01-06
K040388NEXT GENERATION SALEM SUMPKendall2004-05-17
K960176DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTERC.R. Bard, Inc.1996-07-24
K926073ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBESurgimark, Inc.1995-05-15
K935781ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAYSherwood Medical Co.1995-01-27
K921104LOPEZ VALVE WITH NG SUMP TUBEIcu Medical, Inc.1992-10-26
K900035WILSON-COOK COLON DECOMPRESSION SETWilson-Cook Medical, Inc.1990-03-07
K880850KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVEKmb Medical Products Co.1988-05-26
K772282HODGE TUBEMallinckrodt Critical Care1978-03-09
K771048CATHETERS, DRAINAGEAxiom Medical, Inc.1977-07-19

Legacy Summary#

summary

FDA Review#

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