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510(k) K031527

Device
MODIFICATION TO CAVERMAP SURGICAL AID
Applicant
BLUE TORCH MEDICAL TECHNOLOGIES
510(k) number
K031527
Product code
FGM  
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-05
Date received
2003-05-15
Regulation
876.4730
Classification name
Probe And Director, Gastro-urology
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FREDERICK TOBIA
Address
180 Wells Ave. Newton MA US 02459 02459

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAGRegulatory & Marketing Services, Inc.1995-02-15

Legacy Summary#

summary

FDA Review#

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