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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K822048
Device Name H-H NERVE ROOT RETRACTOR
Applicant
HOLTER-HAUSNER INTL.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOLTER-HAUSNER INTL.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.4535
Classification Product Code
HAO  
Date Received07/12/1982
Decision Date 07/22/1982
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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