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510(k) K882072

Device
ORTHOPAEDIC AND SPINAL RING CURRETTES
Applicant
KARLIN TECHNOLOGY, INC.
510(k) number
K882072
Product code
JXH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-17
Date received
1988-05-17
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
MARK WEIDHAAS
Address
330 Washington St. Suite 314 Marina Del Rey CA US 90292 90292

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
K873688ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIALDentsply Intl.1987-10-26

Legacy Summary#

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FDA Review#

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