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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K791167
Device Name DEXIDE DISPOSABLE PREP PAD
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 Number880.5300
Classification Product Code
FRL  
Date Received06/25/1979
Decision Date 08/03/1979
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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