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510(k) K874045

Device
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
Applicant
AMERICAN PHARMASEAL DIV. AHSC
510(k) number
K874045
Product code
NWU  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-03
Date received
1987-10-05
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#

Contact
ROBERT T MERRICK
Address
27200 N. Tourney Rd. Post Office Box 5900 Valencia CA US 91355 91355

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
K813332BRISTOL BALLON INTRODUCER, MANDRIL SETInmed Corp.1981-12-14

Legacy Summary#

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FDA Review#

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