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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name methyl methacrylate for aneurysmorrhaphy
510(k) Number K873688
Device Name ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Applicant Contact JOHN SEMMELMAN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Correspondent Contact JOHN SEMMELMAN
Regulation Number882.5030
Classification Product Code
JXH  
Date Received09/10/1987
Decision Date 10/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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