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510(k) K873688

Device
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
Applicant
DENTSPLY INTL.
510(k) number
K873688
Product code
JXH  
Decision
Substantially Equivalent (SESE)
Decision date
1987-10-26
Date received
1987-09-10
Regulation
882.5030
Classification name
Methyl Methacrylate For Aneurysmorrhaphy
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN SEMMELMAN
Address
570 W. College Ave. P.O. Box 872 York PA US 17405 17405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JXH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071776ANEUROPLASTIC, MODEL 43-1290Codman & Shurtleff, Inc.2007-07-26
K882072ORTHOPAEDIC AND SPINAL RING CURRETTESKarlin Technology, Inc.1988-06-17

Legacy Summary#

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FDA Review#

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