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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K833720
Device Name TRANSTHORACIC/TRANSABDOMINAL-TRAY
Applicant
Applied Medical Devices, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Applied Medical Devices, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GDM  
Date Received10/24/1983
Decision Date 05/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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