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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K897120
Device Name EQUIP COVERS, STERILE
Applicant
AMEDIC USA
OXENSTIERNSGATAN 31
115 27 STOCKHOLM
SWEDEN,  SE
Applicant Contact THEO RUSSO-LARSSON
Correspondent
AMEDIC USA
OXENSTIERNSGATAN 31
115 27 STOCKHOLM
SWEDEN,  SE
Correspondent Contact THEO RUSSO-LARSSON
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/26/1989
Decision Date 01/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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