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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K843885
Device Name PERCUTANEOUS ASPIRATION BIOPSY TRAY
Applicant
Applied Medical Devices, Inc.
7248 S. Tucson Way
Centennial,  CO  80112
Applicant Contact GARY BRUNNER
Correspondent
Applied Medical Devices, Inc.
7248 S. Tucson Way
Centennial,  CO  80112
Correspondent Contact GARY BRUNNER
Date Received10/02/1984
Decision Date 12/19/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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