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510(k) K964561

Device
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
Applicant
BIOENTERICS CORP.
510(k) number
K964561
Product code
FDG  
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-11
Date received
1996-11-13
Regulation
876.4530
Classification name
Retractor, Fiberoptic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KEITH LOWREY
Address
1035 A. Cindy Ln. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945421CHAKOFF ENDOSCOPYStephen Chakoff, Inc.1994-12-23

Legacy Summary#

summary

FDA Review#

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