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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Syringe, Air And/Or Water
510(k) Number K923876
Device Name RISKONTROL SINGLE USE
Applicant
Riskontrol
524 E. Coronado Rd.
Santa Fe,  NM  87501
Applicant Contact ERICK F CARLGREN
Correspondent
Riskontrol
524 E. Coronado Rd.
Santa Fe,  NM  87501
Correspondent Contact ERICK F CARLGREN
Regulation Number872.4565
Classification Product Code
ECB  
Date Received08/03/1992
Decision Date 04/05/1993
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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