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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K934428
Device Name ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103 -1625
Applicant Contact FRANK J FUCILE
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103 -1625
Correspondent Contact FRANK J FUCILE
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/10/1993
Decision Date 12/30/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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