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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Legging, Compression, Non-Inflatable
510(k) Number K903532
Device Name UNNA-SLEEVE(TM)
Applicant
Aci Medical, Inc.
9249 Glenoaks Bl.
Sun Valley,  CA  91352
Applicant Contact ED ARKANS
Correspondent
Aci Medical, Inc.
9249 Glenoaks Bl.
Sun Valley,  CA  91352
Correspondent Contact ED ARKANS
Regulation Number880.5780
Classification Product Code
LLK  
Date Received08/06/1990
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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