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510(k) K951093

Device
KAB SYSTEM
Applicant
KING SYSTEMS CORP.
510(k) number
K951093
Product code
BSF  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-24
Date received
1995-03-09
Regulation
868.5310
Classification name
Absorber, Carbon-dioxide
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL A LEAGRE
Address
15011 Herriman Blvd. P.O. Box 1138 Noblesville IN US 46060 46060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852071OHMEDA GMS ABOSORBEROhmeda Medical1985-07-15
K843422OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOROhmeda Medical1984-10-23
K834535NITROUS OXIDE RECYCLERG & L Unltd.1984-06-07
K833452OHIO GMS ABSORBERAirco/Ohio Medical Products1983-11-29
K821144OHIO ABSORBEROhio Medical Products1982-05-28
K801255PENLON JUMBO CARBON DIOXIDE ABSORBERPenlon, Inc.1980-06-04
K760076ABSORBER, ANESTHESIA CIRCLE SYS, CO2Fraser Sweatman, Inc.1976-07-16

Legacy Summary#

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FDA Review#

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