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510(k) K780365

Device
OXYGEN/NITROUS OXIDE OUTLET
Applicant
SPICA, INC.
510(k) number
K780365
Product code
CAM  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-30
Date received
1978-03-06
Regulation
868.6885
Classification name
Yoke Assembly, Medical Gas
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 CAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935283YOKE ASSEMBLY MEDICAL GASAmerican Gage & Medical, Inc.1994-03-11
K851215T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTERPenox Technologies, Inc.1985-06-18
K851216PENOX DUAL FEED MANIFOLDPenox Technologies, Inc.1985-06-18
K851217PENOX DUAL FLOW MINIFOLDPenox Technologies, Inc.1985-06-18
K851219FILL HOSE SAFETY ADAPTERPenox Technologies, Inc.1985-06-18
K840326GAS SUPPLY MANIFOLD SIEMENS-ELEMA ABSiemens Elema AB1984-06-07
K770426OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDEBel-Med, Inc.1977-03-15

Legacy Summary#

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FDA Review#

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