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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 K872868
Device Name ASPEN ESMARK BANDAGE
Applicant
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Applicant Contact JOHNSON
Correspondent
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Correspondent Contact JOHNSON
Regulation Number880.5075
Classification Product Code
FQM  
Date Received07/21/1987
Decision Date 07/31/1987
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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