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510(k) K945421

Device
CHAKOFF ENDOSCOPY
Applicant
STEPHEN CHAKOFF, INC.
510(k) number
K945421
Product code
FDG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-23
Date received
1994-11-04
Regulation
876.4530
Classification name
Retractor, Fiberoptic
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
FRANK GOLDFARB
Address
15405 Southwest 72 Ct. Miami FL US 33157 33157

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FDG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964561ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TABioenterics Corp.1997-02-11

Legacy Summary#

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FDA Review#

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