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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Elastic
510(k) Number K771758
Device Name ELASTOMULL GAUZE BANDAGE
Applicant
Beiersdorf, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beiersdorf, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5075
Classification Product Code
FQM  
Date Received09/19/1977
Decision Date 10/13/1977
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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