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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air Filter Portable Apparatus
510(k) Number K190027
Device Name SteriStay
Applicant
Toul Meditech AB
Tunbytorpsgatan 31
Vasteras,  SE 72137
Applicant Contact Tomas Hansson
Correspondent
Toul Meditech AB
Tunbytorpsgatan 31
Vasteras,  SE 72137
Correspondent Contact Tomas Hansson
Regulation Number878.5070
Classification Product Code
ORC  
Date Received01/07/2019
Decision Date 05/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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