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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K844512
Device Name DART DAILY AIR REMOVAL TEST
Applicant
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Applicant Contact JAMES A SPALLINA
Correspondent
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Correspondent Contact JAMES A SPALLINA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received11/20/1984
Decision Date 03/21/1985
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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