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510(k) K813332

Device
BRISTOL BALLON INTRODUCER, MANDRIL SET
Applicant
INMED CORP.
510(k) number
K813332
Product code
NWU  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-14
Date received
1981-11-24
Regulation
876.1500
Classification name
Endoscope Introducer Kit
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NWU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933268CANDELA GUIDEWIRECandela Laser Corp.1994-02-10
K874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERAmerican Pharmaseal Div. Ahsc1987-12-03

Legacy Summary#

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FDA Review#

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