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510(k) K911918

Device
SWIVEL HORSESHOE HEADREST
Applicant
Codman & Shurtleff, Inc.
510(k) number
K911918
Product code
HBM  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-17
Date received
1991-04-30
Regulation
882.4440
Classification name
Headrest, Neurosurgical
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J COURAGE
Address
41 Pacella Park Dr. Randolph Industrial Park Randolph MA US 02368 02368

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
K822169SURGICAL HEAD SUPPORTKelleher Corp.1982-08-20

Legacy Summary#

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FDA Review#

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