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510(k) K894618

Device
INAMED RHEMO-D (TM) DILATOR
Applicant
INAMED DEVELOPMENT CO.
510(k) number
K894618
Product code
FFP  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-18
Date received
1989-07-20
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
ELLEN DUKE
Address
1035 A. Cindy Ln. Carpinteria CA US 93013 93013

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
K884713COLONIC BALLOON DIALATORSPrimrose Medical, Inc.1989-09-29
K830354COLORECTAL DILATORCleveland Medical Supply & Services1983-05-27

Legacy Summary#

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FDA Review#

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