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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 K830332
FOIA Releasable 510(k) K830332
Device Name BUDDE-HALO RETRACTOR
Applicant
OHIO MEDICAL INSTRUMENT CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OHIO MEDICAL INSTRUMENT CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.4800
Classification Product Code
GZT  
Date Received02/01/1983
Decision Date 03/02/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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