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510(k) K884713

Device
COLONIC BALLOON DIALATORS
Applicant
PRIMROSE MEDICAL, INC.
510(k) number
K884713
Product code
FFP  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-29
Date received
1988-11-08
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#

Contact
FLETCHER LONGLEY
Address
20 Cabot Rd. Woburn MA US 01801 01801

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
K830354COLORECTAL DILATORCleveland Medical Supply & Services1983-05-27

Legacy Summary#

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FDA Review#

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