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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name applier, staple, surgical,
510(k) Number K823888
Device Name 3M FRASCIA STAPLING SYSTEM
Applicant
3M COMPANY
8124 PACIFIC AVE.
WHITE CITY,  OR  97503
Correspondent
3M COMPANY
8124 PACIFIC AVE.
WHITE CITY,  OR  97503
Regulation Number878.4800
Classification Product Code
GEF  
Date Received12/27/1982
Decision Date 01/09/1983
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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