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510(k) K944384

Device
ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
Applicant
REGULATORY & MARKETING SERVICES, INC.
510(k) number
K944384
Product code
FGM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-15
Date received
1994-09-07
Regulation
876.4730
Classification name
Probe And Director, Gastro-urology
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PATRICK J LAMB
Address
1247 Florida Ave. Palm Harbor FL US 34682 34682

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FGM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041732CAVERMAP SURGICAL AIDBlue Torch Medical Technologies2004-09-21
K031527MODIFICATION TO CAVERMAP SURGICAL AIDBlue Torch Medical Technologies2003-06-05
K010098MODIFICATION TO CAVERMAP SURGICAL AIDUromed Corp.2001-02-01
K993436CAVERMAP SURGICAL AIDUromed Corp.2000-02-11
K944378ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.1995-02-15
K944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.1995-02-15

Legacy Summary#

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FDA Review#

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