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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K833187
Device Name HALL OSTEON
Applicant
AMSCO CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMSCO CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4820
Classification Product Code
GET  
Date Received09/19/1983
Decision Date 10/31/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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