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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Non-Powered
510(k) Number K821644
Device Name VACUUM WAND AND UNI-READER
Applicant
Fred Sammons, Inc.
145 Tower Dr.
Burr Ridge,  IL  60521
Applicant Contact Clark L Sabine
Correspondent
Fred Sammons, Inc.
145 Tower Dr.
Burr Ridge,  IL  60521
Correspondent Contact Clark L Sabine
Regulation Number890.3700
Classification Product Code
ILP  
Date Received06/03/1982
Decision Date 06/11/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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