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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K895704
Device Name ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE
Applicant
Pymah Corp., Ati Div.
Regulatory Consultant
8904 Paddock Ln.
Potomac,  MD  20854
Applicant Contact L KONOPKO
Correspondent
Pymah Corp., Ati Div.
Regulatory Consultant
8904 Paddock Ln.
Potomac,  MD  20854
Correspondent Contact L KONOPKO
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/22/1989
Decision Date 03/08/1990
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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