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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saw, pneumatically powered
510(k) Number K801737
Device Name STERNUM SAW
Applicant
AMSCO CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMSCO CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4820
Classification Product Code
KFK  
Date Received07/25/1980
Decision Date 08/20/1980
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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