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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, orthopedic, pneumatic powered & accessory/attachment
510(k) Number K781979
Device Name SURGAIRTOME TWO
Applicant
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received11/27/1978
Decision Date 12/20/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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