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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K902517
Device Name NEUROSURGICAL HEADFRAME ACCESSORIES
Applicant
Sims Surgical, Inc.
15 Kit St.
P.O. Box 724
Keene,  NH  03431
Applicant Contact JOHN D FORSTER
Correspondent
Sims Surgical, Inc.
15 Kit St.
P.O. Box 724
Keene,  NH  03431
Correspondent Contact JOHN D FORSTER
Regulation Number882.4800
Classification Product Code
GZT  
Date Received06/07/1990
Decision Date 07/03/1990
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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