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510(k) K923818

Device
O.R. CONCEPTS' IRRIGATING KITTNER
Applicant
O.R. CONCEPTS, INC.
510(k) number
K923818
Product code
FGS  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-07
Date received
1992-07-30
Regulation
876.1500
Classification name
Carrier, Sponge, Endoscopic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN MAYALL
Address
200 N. Oak St. Roanoke TX US 76262 76262

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FGS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933604QB II BLUNT DISSECTORJoyce M. Shotwell, M.D.1993-09-23
K931854ENDOSCOPIC BLUNT DISSECTING INSTRUMENTMayaguez Medical Center1993-08-10
K822194ENDOSCOPIC SPONGE CARRIERKelleher Corp.1982-08-27

Legacy Summary#

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FDA Review#

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