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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K813607
Device Name ACKRAD N-DO VAGE TUBE
Applicant
Ackrad Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ackrad Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5475
Classification Product Code
FQH  
Date Received12/29/1981
Decision Date 02/05/1982
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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