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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 K800280
Device Name MEDSPEC RUBBER ELASTIC BANDAGES
Applicant
Medspec Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medspec Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5075
Classification Product Code
FQM  
Date Received02/05/1980
Decision Date 03/12/1980
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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