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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Suturing, Disposable
510(k) Number K801976
Device Name SCANLAN STERNUM NEEDLE-SUTURE
Applicant
SCANLAN INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SCANLAN INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GAB  
Date Received08/19/1980
Decision Date 09/26/1980
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
Predetermined Change
Control Plan Authorized		 No
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