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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K002990
Device Name VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
Applicant
Vascular Technology Incorporated
175 Cabot St.
Lowell,  MA  01854
Applicant Contact DAVID L REGAN
Correspondent
Vascular Technology Incorporated
175 Cabot St.
Lowell,  MA  01854
Correspondent Contact DAVID L REGAN
Regulation Number882.4460
Classification Product Code
HBL  
Date Received09/25/2000
Decision Date 11/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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