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510(k) K830354

Device
COLORECTAL DILATOR
Applicant
CLEVELAND MEDICAL SUPPLY & SERVICES
510(k) number
K830354
Product code
FFP  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-27
Date received
1983-02-03
Regulation
876.5450
Classification name
Dilator, Rectal
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
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 FFP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964634ANOKRYOMk Conquest Intl., Inc.1997-06-06
K901426COLONIC BALLOON DILATORTelemed Systems, Inc.1990-06-21
K894618INAMED RHEMO-D (TM) DILATORInamed Development Co.1990-01-18
K884713COLONIC BALLOON DIALATORSPrimrose Medical, Inc.1989-09-29

Legacy Summary#

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FDA Review#

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