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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K881333
Device Name OLYMPIA ALLOY
Applicant
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact MARCY KRAMER
Correspondent
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact MARCY KRAMER
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received03/29/1988
Decision Date 04/21/1988
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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