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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Basin, Emesis
510(k) Number K760085
Device Name BASIN, STERILE (#3200)
Applicant
Concord Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Concord Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6730
Classification Product Code
FNY  
Date Received06/21/1976
Decision Date 07/20/1976
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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