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510(k) K822169

Device
SURGICAL HEAD SUPPORT
Applicant
KELLEHER CORP.
510(k) number
K822169
Product code
HBM  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-20
Date received
1982-07-23
Regulation
882.4440
Classification name
Headrest, Neurosurgical
Medical specialty
Neurology
Review panel
Neurology
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 HBM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K911917CODMAN PEDIATRIC HORSESHOE HEADRESTCodman & Shurtleff, Inc.1991-07-17
K911918SWIVEL HORSESHOE HEADRESTCodman & Shurtleff, Inc.1991-07-17

Legacy Summary#

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FDA Review#

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