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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Boiling Water
510(k) Number K843234
Device Name CITOMAT AUTOCLAVES
Applicant
Lic-Orthion
2101 L St. Nw
Washington,  DC  20037 -
Applicant Contact RODNEY R MUNSEY
Correspondent
Lic-Orthion
2101 L St. Nw
Washington,  DC  20037 -
Correspondent Contact RODNEY R MUNSEY
Regulation Number872.6710
Classification Product Code
ECG  
Date Received08/17/1984
Decision Date 10/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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