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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Periodontic
510(k) Number K890333
Device Name ALBUMIN REAGENT
Applicant
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Applicant Contact RAYMOND L PAVITT
Correspondent
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Correspondent Contact RAYMOND L PAVITT
Regulation Number872.4565
Classification Product Code
EIX  
Date Received01/23/1989
Decision Date 02/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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