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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K935621
Device Name CUSTOM ENT PACKS
Applicant
Associated Medical
11140 Bren Rd., W.
Minnetonka,  MN  55343
Applicant Contact SCOTT WIEST
Correspondent
Associated Medical
11140 Bren Rd., W.
Minnetonka,  MN  55343
Correspondent Contact SCOTT WIEST
Regulation Number878.4800
Classification Product Code
LRP  
Date Received11/22/1993
Decision Date 03/30/1994
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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