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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827292
Device Name MODEL IC 3000
Applicant
Xonics Medical Systems, Inc.
515 E. Touhy Ave.
Des Plaines,  IL  60018
Correspondent
Xonics Medical Systems, Inc.
515 E. Touhy Ave.
Des Plaines,  IL  60018
Date Received06/07/1982
Decision Date 07/09/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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