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510(k) K801255

Device
PENLON JUMBO CARBON DIOXIDE ABSORBER
Applicant
PENLON, INC.
510(k) number
K801255
Product code
BSF  
Decision
Substantially Equivalent (SESE)
Decision date
1980-06-04
Date received
1980-05-28
Regulation
868.5310
Classification name
Absorber, Carbon-dioxide
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
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 BSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951093KAB SYSTEMKing Systems Corp.1995-03-24
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
K760076ABSORBER, ANESTHESIA CIRCLE SYS, CO2Fraser Sweatman, Inc.1976-07-16

Legacy Summary#

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FDA Review#

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