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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K791169
Device Name DEXIDE DISPOSABLE SWAB STICK
Applicant
Dexide, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dexide, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6025
Classification Product Code
KXF  
Date Received06/25/1979
Decision Date 07/30/1979
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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