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510(k) K822194

Device
ENDOSCOPIC SPONGE CARRIER
Applicant
KELLEHER CORP.
510(k) number
K822194
Product code
FGS  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-27
Date received
1982-07-23
Regulation
876.1500
Classification name
Carrier, Sponge, Endoscopic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K923818O.R. CONCEPTS' IRRIGATING KITTNERO.R. Concepts, Inc.1993-04-07

Legacy Summary#

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FDA Review#

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